FDA Registration Active 🇩🇪 Germany

PROFYLE/BONE SCREW 1.2X12mm S/T

Reg #: 8010177 · FEI: 3002821504 · Expires 2025
Products
1
Proprietary Names
316
Establishment Types
1
Classifications
1

Registration Details

Registration Name
STRYKER LEIBINGER GMBH & CO. KG
Registration Number
8010177
FEI Number
3002821504
Status
Active
Expiry Year
2025
Initial Importer
No
Address
BOTZINGER STRASSE 39-41
City
FREIBURG Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K062498

Owner / Operator

Firm Name
STRYKER CORP.
Operator Number
1811755
Address
4100 East Milham Ave.
City
Kalamazoo
State
MI
Postal Code
49001
Country
US

Products

Device Name Product Code
Plate, Fixation, Bone HRS

Proprietary Names

PROFYLE/BONE SCREW 1.2X12mm S/T OBLIQUE L PLATE 6H RIGHT 2.3X20mm BONE SCREWSCROSSPINSELFTAPPING 2.3 M PROFYLE HAND LOCK T-PLATE,NAR,6H PROFYLE/S PLATE MED STR 4HOLE PROFYLE/BONE SCREW 1.7X5mm S/T PROFYLE/XS 3-D PLATE 2X2 HOLE PROFYLE/M COMP PLATE 90? REG 10H L PROFYLE HAND COMP PLATE,STRAI,BAR,5H 1.7X11MM LOCKING SCREWS,CROSS-PIN,SELF-T 1.7X7MM LOCKING SCREWS,CROSS-PIN,SELF-T 1.7X12MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/BONE SCREW 2.3X24mm S/T 1.7 S VARIAX HAND LOCK ROTATION PLATE,5H 1.9X5mm EMERG SCREWSCROSSPINSELFT 2.3X24MM LOCKING SCREWS,CROSS-PIN,SELF-T 1.7 S PROFYLE HAND LOCK 3-D PLATE,4X2H PROFYLE/S PLATE T 90? REG 7H 2.3 M PROFYLE HAND LOCK PLATE STRAIGHT BAR 4H PROFYLE/BONE SCREW 2.3X23mm S/T PROFYLE/BONE SCREW 1.7X7mm S/T PROFYLE/XS 90DEG PLATE 8 HOLE NA PROFYLE/S CONDYLAR PLATE BAR 5H RT OBLIQUE L PLATE 6H LEFT PROFYLE/S T PLATE 90? 10H REG 1.7X6mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/L COMP PLATE T LT OBQE6H 1.4X5mm EMERG SCREWSCROSSPINSELFT PROFYLE/BONE SCREW 2.3X21mm S/T L PROFYLE HAND COMP PLATE,STRAI,BAR,8H PROFYLE/BONE SCREW 2.3X28mm S/T 2.3 M PROFYLE HAND LOCK 3-D PLATE,3X2H 1.2X16mm BONE SCREWSCROSSPINSELFT PROFYLE/BONE SCREW 1.7X23mm S/T PROFYLE/BONE SCREW 1.2X4mm S/T PROFYLE/M PLATE L 90? REG RT 6H 1.7 S PROFYLE HAND LOCK ROTATION PLATE,5H 1.7X9mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/L COMP PLATE 4H W/BAR PROFYLE/BONE SCREW 2.3X16mm S/T 1.7 S PROFYLE HAND LOCK 3-D REPL PL,4X2H PROFYLE/1.7S-S PLATE 16H STR 2.3 M VARIAX HAND LOCK ROTATION PLATE,5H M PROFYLE HAND COMP T-PLATE,NAR,6H PROFYLE/BONE SCREW 1.7X17mm S/T PROFYLE/BONE SCREW 2.3X18mm S/T 1.4X3mm EMERG SCREWSCROSSPINSELFT PROFYLE/BONE SCREW 2.3X17mm S/T M PROFYLE HAND COMP T-PLATE,REG,7H PROFYLE/BONE SCREW 2.3X15mm S/T PROFYLE/S PLATE T 90? NRW 6H PROFYLE/3D PLATE 2.3X12mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/M 3-D PLATE 3X2 HOLE PROFYLE/EMERG BONE SCREW 2.5X8mm L PROFYLE HAND COMP T-PLATE,OBLI,LE,6H PROFYLE/M COMP PLATE TBVL NRW R6H PROFYLE/L COMP PLATE STR 8H PROFYLE/BONE SCREW 1.2X18mm S/T 1.7X5mm BONE SCREWSCROSSPINSELFTAPPING L PROFYLE HAND COMP PLATE,STRAI,BAR,4H PROFYLE/BONE SCREW 2.3X26mm S/T PROFYLE/EMERG BONE SCREW 1.9X10 S/T 1.7X15mm BONE SCREWSCROSSPINSELFTAPPING 1.7 S PROFYLE HAND LOCK Z-PLATE,NAR,9H 2.3X6mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/M CONDYLAR PLATE RT 6H 2.3X15mm BONE SCREWSCROSSPINSELFTAPPING 1.7X24mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/BONE SCREW 1.7X18mm S/T L PROFYLE HAND COMP L-PLATE,LE,6H PROFYLE/M COMP PLATE L-SHAPE PROFYLE/BONE SCREW 1.7X10mm S/T WASHER FOR 1.7 mm BONE SCREWS 1.7X7mm BONE SCREWSCROSSPINSELFTAPPING 2.3 M PROFYLE HAND LOCK 3-D PLATE,4X2H 1.2X5mm BONE SCREWSCROSSPINSELFT PROFYLE/M COMP PLATE STR 5H 1.7X15MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/BONE SCREW 2.3X34mm S/T L PROFYLE HAND COMP T-PLATE,6H 1.7X11mm BONE SCREWSCROSSPINSELFTAPPING 2.3 M PROFYLE HAND LOCK PLATE,STRAI,4H PROFYLE/BONE SCREW 1.2X13mm S/T PROFYLE/BONE SCREW 1.2X14mm S/T PROFYLE/S CONDYLAR PLATE 1 HOLE PROFYLE/M PLATE STR MED 4H 1.2X6mm BONE SCREWSCROSSPINSELFT 2.3 M PROFYLE HAND LOCK 3-D PLATE,2X2+2H 2.3 M PROFYLE HAND LOCK L-PLATE,LE,6H 2.3X8mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/XS 3-D PLATE 3X2 HOLE PROFYLE/BONE SCREW 1.2X11mm S/T PROFYLE/BONE SCREW 1.7X21mm S/T PROFYLE/BONE SCREW 2.3X8mm S/T 1.7X14MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/EMERG BONE SCREW 2.5X10mm 1.2X20mm BONE SCREWSCROSSPINSELFT 1.7X8MM LOCKING SCREWS,CROSS-PIN,SELF-T 1.7X8mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/BONE SCREW 1.2X6M S/T PROFYLE/BONE SCREW 1.2X10mm S/T 1.7 S PROFYLE HAND LOCK L-PLATE,LE,6H 1.7 S PROFYLE HAND LOCK T-PLATE,NAR,6H PROFYLE/EMERG BONE SCREW 1.9X8 S/T PROFYLE/BONE SCREW 2.3X19mm S/T 2.3X22MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/BONE SCREW 2.3X12mm S/T M PROFYLE HAND COMP PLATE,STRAI,6H 2.3X9mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/M COMP PLATE TBVL NRW L6H PROFYLE/S 3-D PLATE 2X2 HOLE PROFYLE/M 3-D PLATE 2X2 HOLE PROFYLE/M 3D PLATE 2X2+2H 2.3 M PROFYLE HAND LOCK LE MC V PLATE,5H PROFYLE/BONE SCREW 2.3X11mm S/T 2.5X6mm EMERG SCREWSCROSSPINSELFT 2.3 M PROFYLE HAND ROTATION PLATE,5H L PROFYLE HAND COMP L-PLATE,RI,6H 2.3 L PROFYLE HAND ROTATION PLATE,5H 1.2X7mm BONE SCREWSCROSSPINSELFT 2.3 M PROFYLE HAND LOCK Z-PLATE,NAR,13H 1.7 S PROFYLE HAND LOCK T-PLATE,WIDE,8H 1.2X9mm BONE SCREWSCROSSPINSELFT PROFYLE/L COMP PLATE L 90? RT6H 1.7 S PROFYLE HAND LOCK PLATE,STRAI,4H PROFYLE/M COMP PLATE L 90? L 6H PROFYLE/M PLATE T BVL NRW LT 6H PROFYLE/BONE SCREW 1.7X11mm S/T 2.3 M PROFYLE HAND LOCK ROTATION PLATE,5H PROFYLE/S PLATE Y-NRW 7H 1.7 S PROFYLE HAND LOCK 3-D PLATE,3X2H 1.7X10mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/M REPLANT PLATE 4X2H M PROFYLE HAND COMP L-PLATE,RI,6H 1.7 S PROFYLE HAND LOCK L-PLATE,RI,6H PROFYLE/M 3-D PLATE 4X2 HOLE PROFYLE/XS PLATE T 90DG NARROW 1.7X18mm BONE SCREWSCROSSPINSELFTAPPING 2.3X26mm BONE SCREWSCROSSPINSELFTAPPING 2.3X18mm BONE SCREWSCROSSPINSELFTAPPING 1.7X18MM LOCKING SCREWS,CROSS-PIN,SELF-T 1.7 S PROFYLE HAND LOCK T-PLATE,REG,7H 1.2X10mm BONE SCREWSCROSSPINSELFT 2.3 M PROFYLE HAND LOCK PLATE,STRAI,16H PROFYLE/M COMP PLATE STR 8H PROFYLE/BONE SCREW 2.3X9mm S/T PROFYLE/EMERG BONE SCREW 1.4X5 PROFYLE/EMERG BONE SCREW 1.4X9 PROFYLE/M CONDYLAR PLATE LT 5H PROFYLE/BONE SCREW 2.3X30mm S/T 1.2X14mm BONE SCREWSCROSSPINSELFT PROFYLE/M COMP PLATE 90? REG 7H 1.7X20MM LOCKING SCREWS,CROSS-PIN,SELF-T 1.7X20mm BONE SCREWSCROSSPINSELFTAPPING 2.3X6MM LOCKING SCREWS,CROSS-PIN,SELF-T 1.7X16mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/XS PLATE T-BEVL NRW RT PROFYLE/M COMP PLATE L BVL LT 6H PROFYLE/S PLATE L 90? REG RT 6H 1.2X8mm BONE SCREWSCROSSPINSELFT PROFYLE/BONE SCREW 1.7X6mm S/T 2.3 M PROFYLE HAND LOCK 3-D REPL PL,4X2H PROFYLE/S PLATE L 90? REG LT 6H L-COMPRESSION PLATE/2.3MM PROFYLE/L COMP PLATE T RT OBQE6H PROFYLE/M PLATE L BVL REG LT 6H 2.3X13mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/BONE SCREW 1.2X20mm S/T M PROFYLE HAND COMP PLATE,STRAI,BAR,4H 1.4X7mm EMERG SCREWSCROSSPINSELFT 2.3X15MM LOCKING SCREWS,CROSS-PIN,SELF-T WASHER FOR 2.3mm BONE SCREWS 1.7 S PROFYLE HAND LOCK T-PLATE,NAR,10H PLATE/CONDYLAR 6H LFT W/LONG M PROFYLE HAND COMP CONDY-PLATE,RI,6H PROFYLE/M CONDYLAR PLATE LT 6H 1.7X22MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/EMERG BONE SCREW 1.9X5 2.3X16mm BONE SCREWSCROSSPINSELFTAPPING 2.3X26MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/BONE SCREW 1.7X22mm S/T PROFYLE/BONE SCREW 1.2X8mm S/T PROFYLE/M COMP PLATE STR 6H 2.5X8mm EMERG SCREWSCROSSPINSELFT 1.7 S PROFYLE HAND LOCK 3-D PLATE,2X2H L PROFYLE HAND COMP T-PLATE,NAR,6H PROFYLE/XS PLATE STGHT 16 HOLE PROFYLE/BONE SCREW 1.7X14mm S/T M ROTATIONAL PLATE PROFYLE/S PLATE STR 16HOLE 2.3X16MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/M PLATE T 90DG REG 7H 1.7X16MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/EMERG BONE SCREW 1.4X3 PROFYLE/M PLATE Y NRW 7H PROFYLE/EMERG BONE SCREW 2.5X6mm 2.3X20MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/S CONDYLAR PLATE 5H RT PROFYLE/S CONDYLAR PLATE BAR 5H LFT PROFYLE/BONE SCREW 2.3X36mm S/T PROFYLE/S 3D PLATE 2X2+2H 1.7 S PROFYLE HAND LOCK PLATE,STRAI,16H PROFYLE/EMERG BONE SCREW 1.4X7 WASHER FOR 1.2 mm BONE SCREWS 2.3X8MM LOCKING SCREWS,CROSS-PIN,SELF-T 2.3 M PROFYLE HAND LOCK RI MC V PLATE,5H PROFYLE/BONE SCREW 1.7X13mm S/T PROFYLE/S PLATE T BVL NRW RT 6H PROFYLE/S CONDYLAR PLATE 5H LFT 1.2X18mm BONE SCREWSCROSSPINSELFT 2.3 M PROFYLE HAND LOCK L-PLATE,RI,6H PROFYLE/S REPLANT PLT 4X2H 2.3 M PROFYLE HAND LOCK 3-D PLATE,2X2H 2.3 M PROFYLE HAND LOCK Y-PLATE,NAR,7H PROFYLE/BONE SCREW 1.2X7mm S/T PROFYLE/M PLATE L BVL REG RT 6H M PROFYLE HAND COMP Y-PLATE,NAR,7H PROFYLE/BONE SCREW 2.3X14mm S/T PROFYLE/BONE SCREW 1.7X20mm S/T 2.3X13mm LOCKING SCREWSCROSSPINSELFT PROFYLE/BONE SCREW 1.2X5mm S/T 2.3X11mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/BONE SCREW 2.3X22mm S/T PROFYLE/M PLATE L 90? REG LT 6H PROFYLE/XS 3-D PLATE 4X2 HOLE PROFYLE/M CONDYLAR PLATE RT 5H PROFYLE/BONE SCREW 2.3X20mm S/T PROFYLE/XS REPLANT PLATE 4X2H PROFYLE/M COMP PLATE STR MED 4H 2.3 M PROFYLE HAND LOCK T-PLATE,WIDE,8H 1.7X14mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/L COMP PLATE 5H W/BAR PROFYLE/1.7S-S PLATE 12H RIGHT 2.3X14mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/M PLATE T BVL NRW RT 6H PROFYLE/S PLATE STGHT 4 HOLE PROFYLE/BONE SCREW 2.3X7mm S/T S-FIXATION PLATE/1.7MM SCREWS 2.3 M PROFYLE HAND LOCK T-PLATE,REG,7H PROFYLE/BONE SCREW 1.2X9mm S/T PROFYLE/L COMP PLATE T 90? 6H M PROFYLE HAND T-PLATE,WIDE,8H PROFYLE/S Z PLATE 9 HOLE 2.3X14MM LOCKING SCREWS,CROSS-PIN,SELF-T 1.9X10mm EMERG SCREWSCROSSPINSELFT PROFYLE/M COMP PLATE Y NRW 7H PROFYLE/BONE SCREW 2.3X6mm S/T 2.3X11MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/S 3-D PLATE 4X2 HOLE L ROTATIONAL PLATE PROFYLE/EMERG BONE SCREW 2.5X12mm PROFYLE/M COMP PLATE STR 4H PROFYLE/1.7S-S PLATE 12H LEFT 2.3X9MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/BONE SCREW 1.7X8mm S/T PROFYLE/BONE SCREW 2.3X32mm S/T PROFYLE/XS 3D PLATE 2X2+2HOLE PROFYLE/M COMP PLATE T 90? NRW6H PROFYLE/XS PLATE T-BEVL NRW LT PROFYLE/L COMP PLATE STR 7H 2.3X22mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/BONE SCREW 1.7X12mm S/T 1.7X6MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/BONE SCREW 2.3X10mm S/T PROFYLE BONECREW 1.7X15MM PROFYLE/XS PLATE STGHT 4 HOLE PROFYLE/L COMP PLATE L 90? LT6H PROFYLE/M COMP PLATE L BVL RT 6H 1.7 S PROFYLE HAND LOCK 3-D PLATE,2X2+2H M PROFYLE HAND ROTATION PLATE,5H PROFYLE/S 3-D PLATE 3X2 HOLE 2.3X24mm BONE SCREWSCROSSPINSELFTAPPING PROFYLE/M PLATE STR 4H L PROFYLE HAND COMP T-PLATE,NAR,10H L PROFYLE HAND ROTATION PLATE,5H PLATE/CONDYLAR 6H RT W/LONGPIN PROFYLE/BONE SCREW 1.7X9mm S/T 2.3X12MM LOCKING SCREWS,CROSS-PIN,SELF-T 2.3X10MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/L COMP PLATE T 90? 10H PROFYLE/L COMP PLATE 6H W/BAR PROFYLE/M V Z-SHAPE 13H 1.9X8mm EMERG SCREWSCROSSPINSELFT PROFYLE/BONE SCREW 1.7X16mm S/T 1.9X12mm EMERG SCREWSCROSSPINSELFT PROFYLE/BONE SCREW 2.3X13mm S/T 1.2X12mm BONE SCREWSCROSSPINSELFT 1.7X24MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/S PLATE T BVL NRW LT 6H PROFYLE/BONE SCREW 2.3X38mm S/T 2.3X18MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/M PLATE T 90? NRW 6H PROFYLE/BONE SCREW 1.7X24mm S/T 2.5X12mm EMERG SCREWSCROSSPINSELFT 1.7X13mm BONE SCREWSCROSSPINSELFTAPPING M PROFYLE HAND COMP L-PLATE,LE,6H 1.7X22mm BONE SCREWSCROSSPINSELFTAPPING 1.7X10MM LOCKING SCREWS,CROSS-PIN,SELF-T L PROFYLE HAND COMP PLATE,STRAI,BAR,6H 2.5X10mm EMERG SCREWSCROSSPINSELFT 1.2X4mm BONE SCREWSCROSSPINSELFT S PROFYLE HAND T-PLATE,WIDE,8H L PROFYLE HAND COMP T-PLATE,OBLI,RI,6H PROFYLE/BONE SCREW 1.7X19mm S/T PROFYLE/BONE SCREW 1.2X16mm S/T 1.7X13MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/M PLATE STR 16H 1.7X5MM LOCKING SCREWS,CROSS-PIN,SELF-T 1.4X9mm EMERG SCREWSCROSSPINSELFT 1.7X12mm BONE SCREWSCROSSPINSELFTAPPING 1.7X9MM LOCKING SCREWS,CROSS-PIN,SELF-T PROFYLE/XS PLATE Y-NRW 5 HOLE PROFYLE/EMERG BONE SCREW 1.9X12 S/T 2.3X10mm BONE SCREWSCROSSPINSELFTAPPING M PROFYLE HAND COMP CONDY-PLATE,LE,6H

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)