DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 2/3, 10MM,LL (800-05-108)

Registration Details

Registration Name: Straits Orthopaedics (MFG) Sdn Bhd
Registration Number: 3004889950
FEI Number: 3004889950
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: 2, Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar
City: Bayan Lepas Pulau Pinang
Country: MY

Owner / Operator

Firm Name: Straits Orthopaedics (Mfg) Sdn Bhd
Operator Number: 10048319
Address: No. 2 Lengkok Teluk Kumbar, Jalan Teluk Kumbar
City: Bayan Lepas
State: Pulau Pinang
Postal Code: 11920
Country: MY
Correspondent: TH SU

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Template	HWT	Class 1	Orthopedic	No	2016-02-11

Proprietary Names

DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 2/3, 10MM,LL (800-05-108) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 5, 22MM (801-05-535) DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 10/11,5MM,LL (800-05-117) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 28, +4MM (L) (803-17-283) ALTIVATE REVERSE GLENOSPHERE TRIAL, 40mm/+4mm (804-06-341) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 40, +4MM (L) (803-17-403) DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 6/7, 10MM,LL (800-05-110) DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 4/5, 10MM,LL (800-05-109) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 44, -3MM (S) (803-17-441) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 44, +4MM (L) (803-17-443) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 32, +4MM (L) (803-17-323) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 2, 16MM (801-05-521) DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 4/5, 5MM,LL (800-05-104) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 32, +7MM (XL) (803-17-324) ALTIVATE REVERSE GLENOSPHERE TRIAL, 36mm/+4mm (804-06-340) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 28, 0MM (M) (803-17-282) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 36, +7MM (XL) (803-17-364) SLT TAPER FEMORAL HEAD TRIAL 32mm OD W/ FLAT X-LONG NECK (18056063) FEMORAL HEAD TRIAL 28mm LONG +3.5mm (APA02123) DYNASTY® STD POLY TRIAL LINER GROUP C 32MM (3304GC32) GLADIATOR® BIPOLAR TRIAL SHELL 36MM (GLBPTS36) CONSERVE® TOTAL HEAD TRIAL (41103800) FEMORAL HEAD TRIAL 28mm XX-LONG +10.5mm (APA02125) PROFEMUR® LONG A/R VAR/VAL 1 TRIAL NECK RADIO OPAQUE RADEL (APA11114) LINEAGE® Plus4 LATERAL TRIAL LINER 28mm 15Deg GROUP 3 (84152803) PROFEMUR® SHORT VAR/VAL 8DG TRIAL NECK RADIO OPAQUE RADEL (APA11152) ADVANCE® ALL POLY PATELLA TRIAL TRI-PEG 41mm (KPTRTP41) LINEAGE® Plus4 LATERAL TRIAL LINER 28mm 0Deg GROUP 2 (84002802) ADVANCE® TRIAL WEDGE 15Deg LEFT LATERAL / RIGHT MEDIAL SIZE 1 (K0053001) ADVANCE® OFFSET BASE TRL BLOCK AUG 5MM LFT MED/RT LAT SZ 4+/5 (K0053122) FEMORAL HEAD TRIAL 32MM SHORT -3.5MM (APA02151) FEMORAL HEAD TRIAL 32MM X-LONG +7MM (APA02154) Lineage Trial Liner 28mm 15 Group 1 (80152801) SLT TAPER FEMORAL HEAD TRIAL 28mm OD W/ FLAT MEDIUM NECK (18056051) FEMORAL HEAD TRIAL 28mm EXTRA LONG +7mm (APA02124) LINEAGE® Plus4 LATERAL TRIAL LINER 28mm 15Deg GROUP 4 (84152804) LINEAGE® Plus4 LATERAL TRIAL LINER 32mm 0Deg GROUP 2 (84003202) PROFEMUR® SHORT A/R 8DG TRIAL NECK RADIO OPAQUE RADEL (APA11132) DYNASTY® 15DG POLY TRIAL GROUP K 54MM ID (3304LK54) DYNASTY® STD POLY TRIAL LINER GROUP G 36MM (3304GG36) PROFEMUR® SHORT STRAIGHT TRIAL NECK RADIO OPAQUE RADEL (APA11102) ADVANCE® TRIAL BLOCK AUGMENT 5mm SIZE 1 (K0053014) GLADIATOR® BIPOLAR TRIAL SHELL 58MM (GLBPTS58) ADVANCE® FLEXION / EXTENSION BLOCK 10mm (K0003010) EVOLUTION® REVISION FLEX/EXT FEMORAL SHIM 4MM (E5003004) ADVANCE® TRIAL BLOCK AUGMENT 5mm SIZE 2/1 Plus (K0053016) ADVANCE® TRIAL WEDGE 15Deg RIGH LATERAL / LEFT MEDIAL SZ 2/1+ (K0053004) Lineage Trial Liner 28mm 15 Group 3 (80152803) EVOLUTION® REVISION FLEX/EXT FEMORAL SHIM 12MM (E5003012) FEMORAL HEAD TRIAL 36MM XL (+7)(APA02148) SLT TAPER FEMORAL HEAD TRIAL 28mm OD W/ FLAT LONG NECK (18056052) CONSERVE TOTAL TRIAL SLEEVE LONG HEAD PROFEMUR (APA0TSL3) PROFEMUR® LONG VAR/VAL 8DG TRIAL NECK RADIO OPAQUE RADEL (APA11154) FEMORAL HEAD TRIAL 32MM MEDIUM +0MM (APA02152) ADVANCE® OFFSET BASE TRL BLOCK AUG 10MM RT MD/LFT LAT SZ 2+/3 (K0053129) GLADIATOR® BIPOLAR TRIAL SHELL 55MM (GLBPTS55) GLADIATOR® BIPOLAR TRIAL SHELL 43MM (GLBPTS43) ADVANCE® FLEXION / EXTENSION BLOCK 20mm (K0003020) ADVANCE® TRIAL BLOCK AUGMENT 10mm SIZE 1 (K0053025) PERFECTA® REDUCED RASP/TRIAL SIZE 10.5 (4703105000) LINEAGE® TRIAL LINER 32mm 15Deg GROUP 2 (80153202) ADVANCE® FLEXION / EXTENSION BLOCK 25mm (K0003025) PROFEMUR® LONG STRAIGHT TRIAL NECK RADIO OPAQUE RADEL (APA11104) DYNASTY® 15DG POLY TRIAL LINER GROUP D 36MM (3304LD36) ADVANCE® FLEXION / EXTENSION BLOCK 17mm (K0003017) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 3 RIGHT 14mm (KIPT314R) Femoral Head Trial 32mm X-Long 8+mm (APA02134) DYNASTY® STD POLY TRIAL LINER GROUP F 36MM (3304GF36) ADVANCE® FLEXION / EXTENSION BLOCK 12mm (K0003012) LINEAGE® TRIAL LINER 32mm 15Deg GROUP 3 (80153203) ADVANCE® OFFSET BASE TRL BLOCK AUG 5MM RT MED/LFT LAT SZ 4+/5 (K0053121) SLT TAPER FEMORAL HEAD TRIAL 36mm OD W/ FLAT X-LONG NECK (18056023) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 3 RIGHT 10mm (KIPT310R) PERFECTA® REDUCED RASP/TRIAL SIZE 12 (4703120000) LINEAGE® Plus4 LATERAL TRIAL LINER 28mm 0Deg GROUP 3 (84002803) LINEAGE® Plus4 LATERAL TRIAL LINER 28mm 0Deg GROUP 1 (84002801) PROFEMUR® SHORT A/R VAR/VAL 2 TRIAL NECK RADIO OPAQUE RADEL (APA11122) ADVANCE® OFFSET BASE TRL BLOCK AUG 5MM RT MED/LFT LAT SZ 3+/4 (K0053119) LINEAGE® Plus4 LATERAL TRIAL LINER 32mm 15Deg GROUP 4 (80152804) ADVANCE® TRIAL BLOCK AUGMENT 5mm SIZE 4/3+ (K0053020) CONSERVE TOTAL TRIAL SLEEVE SHORT HEAD PROFEMUR (APA0TSS3) ADVANCE® OFFSET BASE TRL BLOCK AUG 10MM LFT MD/RT LAT SZ 1+/2 (K0053128) PROFEMUR® LONG A/R 15DG TRIAL NECK RADIO OPAQUE RADEL (APA11144) FEMORAL HEAD TRIAL 28mm MEDIUM +0 (APA02122) PROFEMUR® SHORT A/R VAR/VAL 1 TRIAL NECK RADIO OPAQUE RADEL (APA11112) SLT TAPER FEMORAL HEAD TRIAL 32mm OD W/ FLAT SHORT NECK (18056060) ADVANCE® TRIAL BLOCK AUGMENT 5mm SIZE 3/2 Plus (K0053018) LINEAGE® Plus4 LATERAL TRIAL LINER 32mm 0Deg GROUP 4 (84003204) LINEAGE® Plus4 LATERAL TRIAL LINER 32mm 15Deg GROUP 2 (84153202) SLT TAPER FEMORAL HEAD TRIAL 28mm OD W/ FLAT XX-LONG NECK (18056054) GLADIATOR® BIPOLAR TRIAL SHELL 57MM (GLBPTS57) LINEAGE® Plus4 LATERAL TRIAL LINER 28mm 15Deg GROUP 2 (84152802) LINEAGE® / TRANSCEND® TRIAL LINER 28mm 0Deg GROUP 4 (84002864) ADVANCE® TRIAL BLOCK AUGMENT 10mm SIZE 1 (K0053026) SLT TAPER FEMORAL HEAD TRIAL 28mm OD W/ FLAT SHORT NECK (18056050) LINEAGE® / TRANSCEND® TRIAL LINER 28mm 0Deg GROUP 2 (82002852) LINEAGE® Plus4 LATERAL TRIAL LINER 32mm 0Deg GROUP 3 (84003203) ADVANCE® TRIAL BLOCK AUGMENT 10mm SIZE 3/2+ (K0053029) EVOLUTION® FLEXION / EXTENSION BLOCK 20MM MODULE(E5001720) Femoral Head Trial 36mm L (+3.5) (APA02146) Dynasty® 15DG Poly Trial Liner Group G 32mm (3304LG32) EVOLUTION® REVISION FLEX/EXT TIBIAL SHIM 5MM (E5004005) ADVANCE® TRIAL WEDGE 15 Deg RIGH LATERAL / LEFT MEDIAL SZ 3/2 Plus (K0053006) ADVANCE® OFFSET BASE TRL BLOCK AUG 5MM LFT MED/RT LAT SZ 3+/4 (K0053120) DYNASTY® STD POLY TRIAL LINER GROUP H 36MM (3304GH36) Lineage/ Transcend 32mm 0 Group 3 (83003258) DYNASTY® STD POLY TRIAL LINER GROUP D 36MM (3304GD36) LINEAGE® / TRANSCEND® 28mm 0Deg GROUP 3 (83002858) LINEAGE® Plus4 LATERAL TRIAL LINER 28mm 0Deg GROUP 4 (84002804) PERFECTA® REDUCED RASP/TRIAL SIZE 13.5 (4703135000) SLT TAPER FEMORAL HEAD TRIAL 28mm OD W/ FLAT X-LONG NECK (18056053) FEMORAL HEAD TRIAL 36MM M (0) (APA02144) EVOLUTION# TIBIA MODULAR 2/4/10 STYLUS ASSEMBLY (E2100210) ADVANCE® TRIAL BLOCK AUGMENT 5mm SIZE 1 (K0053013) ADVANCE# ALL POLY PATELLA TRIAL TRI-PEG 38mm (KPTRTP38) FEMORAL HEAD TRIAL 28mm SHORT -3.5mm (APA02121) PERFECTA® REDUCED RASP/TRIAL SIZE 11.2 (4703112000) PROFEMUR® LONG A/R VAR/VAL 2 TRIAL NECK RADIO OPAQUE RADEL (APA11124) LINEAGE® Plus4 LATERAL TRIAL LINER 32mm 15Deg GROUP 3 (84153203) DYNASTY® STD POLY TRIAL GROUP J 50MM ID (3304GJ50) PROFEMUR® LONG A/R 8DG TRIAL NECK RADIO OPAQUE RADEL (APA11134) EVOLUTION® FLEX / EXT BLOCKS 17MM SIZE 5-8 (E5001758) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 3 RIGHT 12mm (KIPT312R) ADVANCE® TRIAL BLOCK AUGMENT 15mm SIZE 1 (K0053038) Femoral Head Trial 36mm S (-3.5) (APA02142) ADVANCE® FLEXION / EXTENSION BLOCK MINUS 2mm (K0003002) DYNASTY® STD POLY TRIAL LINER GROUP B 28MM (3304GB28) APA0TSM0 CONSERVE® TOTAL TRIAL SLEEVE MEDIUM HEAD PROFEMUR® TRIAL LINER RIM-LOCK STANDARD PROCOTYL® L / O" 36 GROUP F (APA09496) Lineage Trial Liner 28mm 15 Group 2 (80152802) DOMED/FINNED ACETABULAR TRIAL LINER 28mm ID 50mm OD (4820285000) PERFECTA® REDUCED RASP/TRIAL SIZE 12.7 (4703127000) LINEAGE® Plus4 LATERAL TRIAL LINER 28mm 15Deg GROUP 1 (84152801) GUARDIAN®TIBIAL SLEEVE SPACER TRIAL 10mm (25101210) SLT TAPER FEMORAL HEAD TRIAL 32mm OD W/ FLAT MEDIUM NECK (18056061) PROFEMUR® SHORT A/R 15DG TRIAL NECK RADIO OPAQUE RADEL (APA11142) FEMORAL HEAD TRIAL 40MM LONG +4MM (APA02141) TRIAL BLOCK AUGMENT 10MM, SIZE 3 (K0053029E, K0053030E) Dynasty® 15DG Poly Trial Liner Group D 32mm (3304LD32) ADVANCE® TRIAL BLOCK AUGMENT 15mm SIZE 2/1+ (K0053040) ADVANCE® TRIAL BLOCK AUGMENT 10mm SIZE 5/4Plus (K0053033) DYNASTY 15DG POLY TRIAL GROUP J 50MM ID (3304LJ50) TRIAL BLOCK AUGMENT 5MM, SIZE 4 (K0053019E, K0053020E) DYNASTY® STD POLY TRIAL LINER GROUP D 32MM (3304GD32) CONSERVE® TOTAL TRIAL SLEEVE +7MM OFFSET FOR PROFEMUR® (APA0TSX7) GLADIATOR® BIPOLAR TRIAL SHELL 46MM (GLBPTS46) ADVANCE® TRIAL BLOCK AUGMENT 15mm SIZE 3/2 Plus (K0053041) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 4 RIGHT 10MM (KIDT410R) TRIAL BLOCK AUGMENT 5MM, SIZE 2 (K0053015E, K0053016E) ADVANCE® TRIAL BLOCK AUGMENT 10mm SIZE 3/2+ (K0053030) TRIAL BLOCK AUGMENT 10MM, SIZE 4 (K0053031E, K0053032E) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 3 RIGHT 17mm (KIPT317R) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 4 LEFT 12mm (KIPT412L) PERFECTA® REDUCED RASP/TRIAL SIZE 9.7 (4703097000) PERFECTA® REDUCED RASP/TRIAL SIZE 15 (4703150000) ADVANCE® TRIAL BLOCK AUGMENT 15mm SIZE 5/4+ (K0053045) EVOLUTION® REVISION FLEX/EXT TIBIAL SHIM 10MM (E5004010) PERFECTA® REDUCED RASP/TRIAL SIZE 9 (4703090000) LINEAGE® TRIAL LINER 22.25mm 15Deg GROUP 0 (80152200) TRIAL BLOCK AUGMENT 15MM, SIZE 4 (K0053043E, K0053044E) EVOLUTION® REV TIB HALF AUG SIZE 2+/3/4 15MM RT MED/LT LAT (E2533152) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 2 LEFT 12MM (KIDT212L) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 2 RIGHT 12mm (KIPT212R) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 5 RIGHT 17MM (KIDT517R) PERFECTA® REDUCED RASP/TRIAL SIZE 14.2 (4703142000) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 2 LEFT 12mm (KIPT212L) EVOLUTION® REV TIB HALF AUG SIZE 2+/3/4 10MM RT MED/LT LAT (E2533102) ADVANCE® ALL POLY PATELLA TRIAL TRI-PEG 26mm - KPTRTP26 Dynasty® 15DG Poly Trial Liner Group F 32mm (3304LF32) LINEAGE® / TRANSCEND® TRIAL LINER 28mm 0 Deg GROUP 1 (81002846) Advance® Trial Block Augment 5mm Size 4/3+ (Lft Lat/ Rt Med Trial) K0053019 ADVANCE® FLEXION / EXTENSION BLOCK 14mm (K0003014) SLT TAPER FEMORAL HEAD TRIAL 36mm OD W/ FLAT SHORT NECK (18056020) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 4 LEFT 14mm (KIPT414L) EVOLUTION® REVISION FLEX/EXT FEMORAL SHIM 8MM (E5003008) TRIAL LINER RIM-LOCK 15 DG LIP PROCOTYL® L / O" 36 GROUP F (APA09472) TRIAL LINER RIM-LOCK 15 DG LIP PROCOTYL® L / O" 36 GROUP G (APA09474) ADVANCE® TRIAL BLOCK AUGMENT 5mm SIZE 3/2+ (K0053017) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 4 RIGHT 10mm (KIPT410R) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 2 RIGHT 12MM (KIDT212R) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 4 LEFT 10mm (KIPT410L) TRIAL BLOCK AUGMENT 10MM, SIZE 5 (K0053033E) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 3 RIGHT 10MM (KIDT310R) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 4 RIGHT 14mm (KIPT414R) Dynasty® 15DG Poly Trial Liner Group E 32mm (3304LE32) DYNASTY® STD POLY TRIAL LINER GROUP E 32MM (3304GE32) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 2 LEFT 10MM (KIDT210L) LINEAGE® / TRANSCEND® 36mm 0deg GROUP 3 (83003658) PROFEMUR® L SLOT BROACH SZ 2 (PR0LSB02) FEMORAL HEAD TRIAL, 32MM X-SHORT (APA02150) TRIAL BLOCK AUGMENT 10 MM, SIZE 1 (K0053025E) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 5 RIGHT 12MM (KIDT512R) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 4 LEFT 12MM (KIDT412L) TRIAL BLOCK AUGMENT 15MM, SIZE 2 (K0053039E) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 4 RIGHT 17MM (KIDT417R) TRIAL ACETABULAR CUP "PROCOTYL® L / O" SIZE 68 GR G (APA09348) TRIAL ACETABULAR CUP "PROCOTYL® L / O" SIZE 48 GR C (APA09328) CERAMIC/METAL LINER POSITIONER "PROCOTYL® L /O" DIA 40 (APA09440) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 4 LEFT 14MM (KIDT414L) UNIVERSAL IMPACTOR (18810211E) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 3 LEFT 14MM (KIDT314L) EVOLUTION® REV CUT THRU CCK, BOX & STEM ADAPTER SIZE 7L (E120537L) TRIAL BLOCK AUGMENT 5MM, SIZE 1 (K0053013E, K0053014E) TRIAL LINER RIM-LOCK STANDARD PROCOTYL® L/O" 40 GROUP F(APA09400) TRIAL BLOCK AUGMENT 15 MM, SIZE 1 (K0053038E) FEMORAL HEAD TRIAL 32mm MEDIUM +0 (APA02132) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 2 RIGHT 14MM (KIDT214R) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 3 LEFT 12MM (KIDT312L) TRIAL BLOCK AUGMENT 15MM, SIZE 1 (K0053037E) EVOLUTION® FLEX / EXT BLOCKS 17MM SIZE 1-4 (E5001714) SLT TAPER FEMORAL HEAD TRIAL 36mm OD W/ FLAT MEDIUM NECK (18056021) DYNASTY® 15DG POLY TRIAL LINER GROUP C 32MM (3304LC32) TRIAL BLOCK AUGMENT 10MM, SIZE 2 (K0053027E, K0053028E) EVOLUTION® REV TIB HALF AUG SIZE 2+/3/4 5MM RT MED/LT LAT (E2533052) EVOLUTION® REVISION FLEX/EXT FEMORAL SHIM 12MM CE (E5003112) Femoral Head Trial 32mm Long +4mm (APA02133) TRIAL LINER RIM-LOCK STANDARD PROCOTYL® L / O" 28 GROUP A (APA09482) PROFEMUR® RENAISSANCE® BROACH REDUCED SZ 14 (PLRB0014) TRIAL BLOCK AUGMENT 5MM, SIZE 3 (K0053017E, K0053018E) TRIAL BLOCK AUGMENT 5MM, SIZE 5 (K0053021E, K0053022E) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 3 LEFT 10mm (KIPT310L) TRIAL BLOCK AUGMENT 15MM, SIZE 3 (K0053041E) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 2 RIGHT 10MM (KIDT210R) PROFEMUR® PRESERVE BROACH SIZE 6 (PRPRBR06) EVOLUTION® CR / CS FEM TRIALS PRIMARY PEGLESS SIZE 8 LEFT (E13018PL) PROFEMUR® PRESERVE BROACH SIZE 2 MOD LENGTH (PPREBR02) FEMORAL HEAD TRIAL, 36MM XX-LONG (APA02149) EVOLUTION® REV CUT THRU CCK, BOX & STEM ADAPTER SIZE 4R (E120534R) PROFEMUR® L SLOT BROACH SZ 3 (PR0LSB03) FEMORAL HEAD TRIAL, 40MM X-LONG (APA02143) Gladiator® G26 Bipolar Trial Shell (47mm) (GL26TS47) DYNASTY® 15DG POLY TRIAL LINER GROUP B 28MM (3304LB28) EVOLUTION® REVISION FLEX/EXT TIBIAL SHIM 5MM CE (E5004105) EVOLUTION® REVISION FLEX/EXT FEMORAL SHIM 4MM CE (E5003104) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 2 LEFT 17mm (KIPT217L) TRIAL ACETABULAR CUP "PROCOTYL® L / O" SIZE 54 GR E (APA09334) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 2 LEFT 10mm (KIPT210L) TRIAL LINER RIM-LOCK STANDARD PROCOTYL® L / O" 32 GROUP E (APA09492) EVOLUTION® REV FEM SPLINED, CONE TRIAL 24MM (E1030024) TRIAL ACETABULAR CUP "PROCOTYL® L / O" SIZE 52 GR E (APA09332) FEMORAL HEAD TRIAL, 36MM X-SHORT (APA02138) EVOLUTION® REV CUT THRU BUSH, ADAPTER CCK SIZE 3-6 LEFT (E630346L) PROFEMUR® L SLOT BROACH SZ 4 (PR0LSB04) Gladiator® G26 Bipolar Trial Shell (48mm) (GL26TS48) PROFEMUR® PRESERVE BROACH SIZE 3 MOD LENGTH (PPREBR03) EVOLUTION® REV CUT THRU CCK, BOX & STEM ADAPTER SIZE 4L (E120534L) PROFEMUR® PRESERVE BROACH SIZE 7 (PRPRBR07) EVOLUTION® REV CUT THRU CCK, BOX & STEM ADAPTER SIZE 7R (E120537R) EVOLUTION® REV CUT THRU CCK, BOX & STEM ADAPTER SIZE 5R (E120535R) TRIAL LINER RIM-LOCK 15 DG LIP PROCOTYL® L / O" 28 GROUP B (APA09464) TRIAL ACETABULAR CUP "PROCOTYL® L / O" SIZE 66 GR G (APA09346) TRIAL LINER RIM-LOCK STANDARD PROCOTYL® L / O" 28 GROUP B (APA09484) TRIAL LINER RIM-LOCK STANDARD PROCOTYL® L / O" 32 GROUP C (APA09488) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 5 LEFT 12MM (KIDT512L) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 2 RIGHT 10mm (KIPT210R) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 3 LEFT 10MM (KIDT310L) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 5 LEFT 14mm (KIPT514L) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 4 RIGHT 14MM (KIDT414R) PROFEMUR® PRESERVE BROACH SIZE 4 (PRPRBR04) PROFEMUR® L SLOT BROACH SZ 9 (PR0LSB09) PROFEMUR® PRESERVE BROACH SIZE 10 (PRPRBR10) GLADIATOR® BIPOLAR TRIAL HEAD PROFEMUR® 22MM (GLBPTH22) Gladiator Bipolar Trial Shell 59mm (GLBPTS59) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 1 LEFT 10MM (KIDT110L) TRIAL BLOCK AUGMENT 10 MM, SIZE 1 (K0053026E) GLADIATOR® BIPOLAR TRIAL HEAD 32MM (GLBPTH32) Gladiator® G26 Bipolar Trial Shell (42mm) (GL26TS42) Gladiator® G26 Bipolar Trial Shell (44mm) (GL26TS44) EVOLUTION® REV CUT THRU TRANS, STEM ADAPTER SIZE 7-8 LEFT (E631078L) EVOLUTION® REV CUT THRU CCK, BOX & STEM ADAPTER SIZE 8R (E120538R) EVOLUTION® REV FEM SPLINED, CONE TRIAL 18MM (E1030018) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 1 LEFT 14MM (KIDT114L) TRIAL ACETABULAR CUP "PROCOTYL® L / O" SIZE 46 GR C (APA09326) Evolution CR/CS Fem Trials Primary Pegless Size 2 Right (E13012PR) EVOLUTION® REV CUT THRU TRANS, STEM ADAPTER SIZE 3-6 LEFT (E631346L) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 5 LEFT 17MM (KIDT517L) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 4 LEFT 17mm (KIPT417L) EVOLUTION® REV CUT THRU CCK, BOX & STEM ADAPTER SIZE 5L (E120535L) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 4 RIGHT 12MM (KIDT412R) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 5 RIGHT 10MM (KIDT510R) EVOLUTION® REV CUT THRU OFFSET, ADAPTER 8MM (E1030003) Gladiator® G26 Bipolar Trial Shell (53mm) (GL26TS53) Slt Taper Femoral Head Trial 22mm OD X-Long Neck (18052207) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 5 LEFT 17mm (KIPT517L) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 5 RIGHT 14MM (KIDT514R) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 4 LEFT 17MM (KIDT417L) TRIAL LINER RIM-LOCK STANDARD PROCOTYL® L / O" 40 GROUP G(APA09402) Slt Taper Femoral Head Trial 22mm OD Medium Neck (18052205) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 2 LEFT 14MM (KIDT214L) ADVANCE® MEDIAL PIVOT INSERT TRIAL SIZE 5 RIGHT 12mm (KIPT512R) ADVANCE® DOUBLE HIGH TRIAL INSERT SIZE 5 LEFT 14MM (KIDT514L) Gladiator® G26 Bipolar Trial Shell (49mm) (GL26TS49) Gladiator Bipolar Trial Shell 48mm (GLBPTS48) TRIAL ACETABULAR CUP "PROCOTYL® L / O" SIZE 64 GR G (APA09344) LOCKING BOLT FOR PROCOTYL® L/O IMPACTOR KNOB (APA09315) PROFEMUR L SLOT BROACH SZ 2 (PR0LSB02) TRIAL LINER RIM-LOCK 15 DG LIP PROCOTYL® L / O" 28 GROUP C (APA09466) PROFEMUR® PRESERVE BROACH SIZE 5 (PRPRBR05) PROFEMUR® L SLOT BROACH SZ 7 (PR0LSB07) ADVANCE® TRIAL STEM EXTENSION 16 x 65mm (K0056516) TRIAL LINER RIM-LOCK 15 DG LIP PROCOTYL® L / O" 32 GROUP D (APA09468) EVOLUTION® REVISION FLEX/EXT FEMORAL SHIM 8MM CE (E5003108) PROFEMUR® L SLOT BROACH SZ 5 (PR0LSB05) PROFEMUR® L CLASSIC EXT OFFSET TRIAL NECK (APA11172) EVOLUTION® REV CUT THRU CCK, BOX & STEM ADAPTER SIZE 3L (E120533L) PROFEMUR® L SLOT BROACH SZ 1 (PR0LSB01) PROFEMUR® L SLOT BROACH SZ 6 (PR0LSB06) PROFEMUR® PRESERVE BROACH SIZE 11 (PRPRBR11) EVOLUTION® REV CUT THRU CCK, BOX & STEM ADAPTER SIZE 6R (E120536R) GLADIATOR® BIPOLAR TRIAL HEAD PERFECTA® 22MM (GLBPTH21) EVOLUTION® REV CUT THRU TRANS, STEM ADAPTER SIZE 3-6 RIGHT (E631346R) PROFEMUR® L SLOT BROACH SZ 8 (PR0LSB08) EVOLUTION® CR / CS FEM TRIALS PRIMARY PEGLESS SIZE 3 RIGHT (E13013PR) PROFEMUR® PRESERVE BROACH SIZE 9 (PRPRBR09) PROFEMUR® L SLOT BROACH SZ 11 (PR0LSB11) PROFEMUR® PRESERVE BROACH SIZE 8 (PRPRBR08) TRIAL LINER RIM-LOCK STANDARD PROCOTYL® L / O" 36 GROUP G (APA09498) PROFEMUR L SLOT BROACH SZ 10 (PR0LSB10) TRIAL LINER RIM-LOCK STANDARD PROCOTYL® L / O" 28 GROUP C (APA09486) Trial Liner Rim-Lock 15 Deg Lip Procotyl L/0 32 Group E (APA09470) Gladiator® G26 Bipolar Trial Shell (45mm) (GL26TS45) TRIAL LINER RIM-LOCK STANDARD PROCOTYL® L / O" 32 GROUP D (APA09490) Gladiator® G26 Bipolar Trial Shell (52mm) (GL26TS52) EVOLUTION® CR / CS FEM TRIALS PRIMARY PEGLESS SIZE 6 RIGHT (E13016PR) EVOLUTION® REVISION FLEX/EXT TIBIAL SHIM 10MM CE (E5004110) Gladiator® G26 Bipolar Trial Shell (TAB) (GL26TS40) EVOLUTION® CR / CS FEM TRIALS PRIMARY PEGLESS SIZE 6 LEFT (E13016PL) EVOLUTION® CR / CS FEM TRIALS PRIMARY PEGLESS SIZE 3 LEFT (E13013PL) TRIAL ACETABULAR CUP "PROCOTYL® L / O" SIZE 56 GR F (APA09336) FEMORAL HEAD TRIAL, 32MM XX-LONG (APA02155) Femoral Head Trial 32mmShort -4mm (APA02131) Evolution CR/CS Fem Trials Primary Pegless Size 2 Left (E13012PL) Gladiator® G26 Bipolar Trial Shell (41mm) (GL26TS41) EVOLUTION® REV CUT THRU CCK, BOX & STEM ADAPTER SIZE 3R (E120533R) EVOLUTION® REV CUT THRU TRANS, STEM ADAPTER SIZE 7-8 RIGHT (E631078R) EVOLUTION® CR / CS FEM TRIALS PRIMARY PEGLESS SIZE 4 RIGHT (E13014PR) GLADIATOR® BIPOLAR TRIAL SHELL 56MM (GLBPTS56) Gladiator Bipolar Trial Shell 51mm (GLBPTS51) Gladiator® G26 Bipolar Trial Shell (50mm) (GL26TS50) Slt Taper Femoral Head Trial 22mm OD Long Neck (18052206) EVOLUTION® REV CUT THRU CCK, BOX & STEM ADAPTER SIZE 6L (E120536L) Prime Lipped Trial Liner 36mm Group G (P3LLTG36) FEMORAL HEAD TRIAL (APA02139) Gladiator® G26 Bipolar Trial Shell (51mm) (GL26TS51) Gladiator® G26 Bipolar Trial Shell (43mm) (GL26TS43) PROFEMUR® PRESERVE BROACH SIZE 1 MOD LENGTH (PPREBR01) PROFEMUR® L SLOT BROACH SZ 10 (PR0LSB10) FEMORAL HEAD TRIAL 22mm MEDIUM +0 (APA02112) Evolution CR/CS Fem Trials Primary Pegless Size 1 (TAB) (E13011PL) Gladiator® G26 Bipolar Trial Shell (46mm) (GL26TS46) EVOLUTION® CR / CS FEM TRIALS PRIMARY PEGLESS SIZE 4 LEFT (E13014PL) Conserve® Total Trial Sleeve 10.5mm Offset For Profemur® (APA0TSXX) Gladiator® G26 Bipolar Trial Shell (55mm) (GL26TS55) Gladiator® G26 Bipolar Trial Shell (54mm) (GL26TS54) PROFEMUR L SLOT BROACH SZ 8 (PR0LSB08) PROFEMUR® PRESVE BROACH SIZE 12 (PRPRBR12) Gladiator Bipolar Trial Shell 47mm (GLBPTS47) Modular Satellite Rod Connector Trials, Right (17441) Modular Satellite Rod Connector Trials, Left (17442) PROFEMUR PRESERVE BROACH SIZE 3 MOD LENGTH (PPREBR03) PROFEMUR L SLOT BROACH SZ 9 (PR0LSB09) PROFEMUR PRESERVE BROACH SIZE 1 MOD LENGTH (PPREBR01) PROFEMUR L SLOT BROACH SZ 1 (PR0LSB01) ADVANCE FLEXION / EXTENSION BLOCK 14mm (K0003014) PERFORM HUMERAL HEAD TRIAL 50X (MWN5016) PERFORM HUMERAL HEAD TRIAL 48X (MWN4820) PERFORM HIGH OFFSET COUPLER (MWN120) PERFORM HUMERAL HEAD TRIAL 43X (MWN4316) PERFORM HUMERAL HEAD TRIAL 52X (MWN5223) PERFORM HUMERAL HEAD TRIAL 48X (MWN4816) PERFORM HUMERAL HEAD TRIAL 39X (MWN3914) PERFORM HUMERAL HEAD TRIAL 37X (MWN3713) PERFORM HUMERAL HEAD TRIAL 43X (MWN4314) PERFORM HUMERAL HEAD TRIAL 54X (MWN5424) PERFORM HUMERAL HEAD TRIAL 56X (MWN5622) 1456-7310, 1456-7320, 1456-7330 Length Trial Short, Medium, Long PERFORM LOW OFFSET COUPLER (MWN110) PERFORM HUMERAL HEAD TRIAL 41X (MWN4115) PERFORM HUMERAL HEAD TRIAL 46X (MWN4617) PERFORM HUMERAL HEAD TRIAL 52X (MWN5219) PERFORM HUMERAL HEAD TRIAL 46X (MWN4619) PERFORM HUMERAL HEAD TRIAL 54X (MWN5420) PERFORM CENTERED COUPLER TRIAL (MWN100) PERFORM HUMERAL HEAD TRIAL 46X (MWN4615) PERFORM HUMERAL HEAD TRIAL 50X (MWN5019) PERFORM HUMERAL HEAD TRIAL 50X (MWN5022) PERFORM HUMERAL HEAD TRIAL 48X (MWN4818) ALTIVATE REVERSE GLENOID PERIPHERAL DRILL, 3.5mm (804-06-331) Bearing Sleeve (881-1-10000-03) Connector Sleeve (881-1-10000-02) SPECIAL, EMPOWR REVISION KNEE KEEL TRIAL, MD 4-8 (S-201750) Discovery Twist Drill 3/16" X 5" (463012-001) Connector Core (881-1-10000-01) McMaster 1986K78 Or Equiv (881-1-10000-04) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 5, 16MM (801-05-533) DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 6/7, 10MM,LL (800-05-120) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 3, 16MM (801-05-525) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 3, 22MM (801-05-527) DDJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 6, 19MM (801-05-538) DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 2/3, 5MM,LL (800-05-103) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 6, 22MM (801-05-539) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 4, 16MM (801-05-529) DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 2/3, 10MM,LL (800-05-118) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 44, 0MM (M) (803-17-442) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 5, 19MM (801-05-534) DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 10/11, 10MM,LL (800-05-112) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 28, +7MM (XL) (803-17-284) DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 10/11, 5MM,LL (800-05-107) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 4, 25MM (801-05-532) DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS,SZ 10/11,10MM,LL (800-05-122) Guide Pin Connector, SFP (881-1-10000) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 28, -3MM (S) (803-17-281) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 2, 22MM (801-05-523) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 2, 19MM (801-05-522) DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 8/9, 10MM,LL (800-05-121) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 40, +7MM (XL) (803-17-404) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 36, 0MM (M) (803-17-362) DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 2/3, 5MM,LL (800-05-113) DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 8/9, 5MM,LL (800-05-106) DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 6/7, 5MM,LL (800-05-115) DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 8/9, 10MM,LL (800-05-111) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 2, 25MM (801-05-524) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 6, 16MM (801-05-537) DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 8/9, 5MM,LL (800-05-116) SPECIAL, EMPOWR REVISION KNEE KEEL TRIAL, LG 9-11 (S-201751) DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 6/7, 5MM,LL (800-05-105) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 3, 19MM (801-05-526) SPECIAL, EMPOWR REVISION KNEE KEEL TRIAL, SM 2-3 (S-201749) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 40, -3MM (S) (803-17-401) McMaster 9642K23 Or Equiv (881-1-10000-05) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 36, +4MM (L) (803-17-363) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 4, 19MM (801-05-530) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 40, 0MM (M) (803-17-402) SPECIAL, EMPOWR REVISION KNEE KEEL TRIAL TOP INSERT (S-201748) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 4, 22MM (801-05-531) DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 4/5, 10MM,LL (800-05-119) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 32, 0MM (M) (803-17-322) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 36, -3MM (S) (803-17-361) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 32, -3MM (S) (803-17-321) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 5, 25MM (801-05-536) DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 4/5, 5MM,LL (800-05-114) ALTIVATE REVERSE GLENOSPHERE TRIAL, 32mm/-6mm (804-06-339) ALTIVATE REVERSE GLENOSPHERE TRIAL, 40mm/NX (804-06-342) FEMORAL HEAD TRIALS, CHOICE SLEEVE, DIA 44, +7MM (XL) (803-17-444) DJO EMPOWR KNEETM SPACER TRIAL 2, SIZE 3, 25MM (801-05-528)

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)