Recon 2.7 mm Locking Screw 40 mm (TLR27-40)

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

Regulatory Submissions

510(k) Number: K221558

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
Screw, Fixation, Bone	HWC	Class 2	Orthopedic	No	2022-11-30
Plate, Fixation, Bone	HRS	Class 2	Orthopedic	No	2022-11-30
Washer, Bolt Nut	HTN	Class 2	Orthopedic	No	2022-11-30

Proprietary Names

Recon 2.7 mm Locking Screw 40 mm (TLR27-40) Recon 2.7mm Non-Locking Screw 16mm (TNR27-16) Recon 2.7mm Non-Locking Screw 28mm (TNR27-28) Recon 2.7 mm Locking Screw 38 mm (TLR27-38) Recon 2.7 mm Locking Screw 50 mm (TLR27-50) Recon 2.7 mm Locking Screw 30 mm (TLR27-30) Recon 2.7mm Non-Locking Screw 18mm (TNR27-18) Recon 2.7 mm Locking Screw 34 mm (TLR27-34) Recon 2.7mm Non-Locking Screw 32mm (TNR27-32) Recon 2.7mm Non-Locking Screw 24mm (TNR27-24) TLS25-10 Met FX Locking Screw 2.5x10mm (Light Blue) TLS20-12 Met FX Locking Screw 2x12mm (Magenta) Y PLATE SHORT - ALPHA (TYA-S) T PLATE MEDIUM (TTP-MD) MINI T PLATE MEDIUM (MTTP-M) TLS25-14 Met FX Locking Screw 2.5x14mm (Light Blue) TLS15-22 Met FX Locking Screw 1.5x22mm (Dark Blue) TNS25-12 Met FX Non-Locking Screw 2.5x12mm (Green) TLS25-24 Met FX Locking Screw 2.5x24mm (Light Blue) TLS15-18 Met FX Locking Screw 1.5x18mm (Dark Blue) TNS15-14 Met FX Non-Locking Screw 1.5x14mm (Bronze) L PLATE LONG - ALPHA (TLP-RL) TLS15-16 Met FX Locking Screw 1.5x16mm (Dark Blue) TNS25-30 Met FX Non-Locking Screw 2.5x30mm (Green) ALPHALOK MET FX SADDLE PLATE-MEDIUM (TP-SADM) WRAP Y PLATE - NARROW (TYW-N) TNS25-18 Met FX Non-Locking Screw 2.5x18mm (Green) STRAIGHT PLATE - THREE HOLES (TSP-3S) MINI STRAIGHT PLATE 5 HOLES (MTSP-5S) Y PLATE MEDIUM - ALPHA (TYA-M) TLS15-10 Met FX Locking Screw 1.5x10mm (Dark Blue) TLS20-16 Met FX Locking Screw 2x16mm (Magenta) TNS20-08 Met FX Non-Locking Screw 2x08mm (Gold) TNS20-16 Met FX Non-Locking Screw 2x16mm (Gold) (TNR27-32) 2.7 mm Non-Locking Screw 32 mm TNS20-20 Met FX Non-Locking Screw 2x20mm (Gold) TNS25-20 Met FX Non-Locking Screw 2.5x20mm (Green) (TNR27-16) 2.7 mm Non-Locking Screw 16 mm TLS25-18 Met FX Locking Screw 2.5x18mm (Light Blue) WRAP Y PLATE - WIDE (TYW-W) Y PLATE SHORT - BETA (TYB-S) (TNR27-12) 2.7 mm Non-Locking Screw 12 mm TNS15-16 Met FX Non-Locking Screw 1.5x16mm (Bronze) Recon MTP Plate Large 0D, 53mm Left (TMP53-0L) TLS25-26 Met FX Locking Screw 2.5x26mm (Light Blue) Met FX 1.3/1.3mm Polyaxial x Monoaxial Drill Guide (TTP13-13) Y PLATE MEDIUM - BETA (TYB-M) TNS15-12 Met FX Non-Locking Screw 1.5x12mm (Bronze) (TNR27-14) 2.7 mm Non-Locking Screw 14 mm Recon Non-Locking Screw 3.5x42mm (TNR35-42) MINI Y PLATE MED - ALPHA (MTYA-M) TNR40-55 Recon 4mm Non-Locking Screw 55mm TNR40-70 Recon 4mm Non-Locking Screw 70mm Recon Locking Screw 3.5x46mm (TLR35-46) MINI Y PLATE MED - BETA (MTYB-M) (TNR27-18) 2.7 mm Non-Locking Screw 18 mm TNS20-14 Met FX Non-Locking Screw 2x14mm (Gold) Recon Non-Locking Screw 3.5x44mm (TNR35-44) L PLATE SHORT - BETA (TLP-LS) TNS25-24 Met FX Non-Locking Screw 2.5x24mm (Green) STRAIGHT PLATE - FOUR HOLES (TSP-4S) TLS25-08 Met FX Locking Screw 2.5x08mm (Light Blue) T PLATE SHORT (TTP-SRT) ALPHALOK MET FX SADDLE PLATE-LONG (TP-SADL) TNS15-08 Met FX Non-Locking Screw 1.5x08mm (Bronze) WRAP Y PLATE - MED (TYW-M) STRAIGHT PLATE - SIX HOLES (TSP-6S) TNR40-50 Recon 4mm Non-Locking Screw 50mm TNS15-18 Met FX Non-Locking Screw 1.5x18mm (Bronze) TLS20-14 Met FX Locking Screw 2x14mm (Magenta) TNS25-08 Met FX Non-Locking Screw 2.5x08mm (Green) TLS25-20 Met FX Locking Screw 2.5x20mm (Light Blue) Recon Tab Plate, 35mm 3 Hole (TTP35-3U) (TNR27-10) 2.7 mm Non-Locking Screw 10 mm (TNR27-26) 2.7 mm Non-Locking Screw 26 mm (TNR27-24) 2.7 mm Non-Locking Screw 24 mm Recon Non-Locking Screw 3.5x34mm (TNR35-34) TLS15-14 Met FX Locking Screw 1.5x14mm (Dark Blue) TNS20-10 Met FX Non-Locking Screw 2x10mm (Gold) Recon Locking Screw 3.5x36mm (TLR35-36) Recon 2.7 mm Locking Screw 20 mm (TLR27-20) TLS25-28 Met FX Locking Screw 2.5x28mm (Light Blue) Y PLATE LONG - BETA (TYB-L) Met FX Locking Screw 1.5x08mm (Dark Blue) (TLS15-08) TNS25-10 Met FX Non-Locking Screw 2.5x10mm (Green) TLS20-20 Met FX Locking Screw 2x20mm (Magenta) TLS25-16 Met FX Locking Screw 2.5x16mm (Light Blue) TLS20-08 Met FX Locking Screw 2x08mm (Magenta) Recon Locking Screw 3.5x38mm (TLR35-38) Recon 2.7 mm Locking Screw 28 mm (TLR27-28) TNS15-22 Met FX Non-Locking Screw 1.5x22mm (Bronze) Recon Locking Screw 3.5x44mm (TLR35-44) Recon Non-Locking Screw 3.5x48mm (TNR35-48) Recon 2.7 mm Locking Screw 24 mm (TLR27-24) Recon 2.7mm Non-Locking Screw 26mm (TNR27-26) T PLATE LONG (TTP-LNG) TNR40-65 Recon 4mm Non-Locking Screw 65mm TLS15-12 Met FX Locking Screw 1.5x12mm (Dark Blue) Recon 2.7mm Non-Locking Screw 36mm (TNR27-36) Recon 2.7mm Non-Locking Screw 40mm (TNR27-40) Recon 2.7 mm Locking Screw 26 mm (TLR27-26) TLS25-22 Met FX Locking Screw 2.5x22mm (Light Blue) Recon 2.7mm Non-Locking Screw 12mm (TNR27-12) Recon 2.7 mm Locking Screw 36 mm (TLR27-36) TCS20-25 MET FX 2MM/2.5MM MET COUNTERSINK Met FX 1.8/1.8mm Polyaxial x Monoaxial Drill Guide (TTP18-18) Recon 2.7mm Non-Locking Screw 22mm (TNR27-22) TNS25-16 Met FX Non-Locking Screw 2.5x16mm (Green) TLS15-20 Met FX Locking Screw 1.5x20mm (Dark Blue) Recon 2.7 mm Locking Screw 32 mm (TLR27-32) Recon 2.7mm Non-Locking Screw 10mm (TNR27-10) L PLATE SHORT - ALPHA (TLP-RS) TLS25-30 Met FX Locking Screw 2.5x30mm (Light Blue) MINI STRAIGHT PLATE 6 HOLES (MTSP-6S) STRAIGHT PLATE - SEVEN HOLES (TSP-7S) Recon 2.7 mm Locking Screw 22 mm (TLR27-22) TNS15-10 Met FX Non-Locking Screw 1.5x10mm (Bronze) STRAIGHT PLATE - EIGHT HOLES (TSP-8S) STRAIGHT PLATE - FIVE HOLES (TSP-5S) Met FX 1.1/1.1mm Polyaxial x Monoaxial Drill Guide (TTP11-11) TNS20-12 Met FX Non-Locking Screw 2x12mm (Gold) TNS20-18 Met FX Non-Locking Screw 2x18mm (Gold) TLS25-12 Met FX Locking Screw 2.5x12mm (Light Blue) TNS15-20 Met FX Non-Locking Screw 1.5x20mm (Bronze) Recon Universal Plate, 31mm Left (TLU-31L) TLS20-18 Met FX Locking Screw 2x18mm (Magenta) MINI STRAIGHT PLATE 7 HOLES (MTSP-7S) TNS25-22 Met FX Non-Locking Screw 2.5x22mm (Green) TNS25-26 Met FX Non-Locking Screw 2.5x26mm (Green) TLS20-22 Met FX Locking Screw 2x22mm (Magenta) TNS25-14 Met FX Non-Locking Screw 2.5x14mm (Green) Y PLATE LONG - ALPHA (TYA-L) MINI T PLATE LONG (MTTP-L) L PLATE LONG - BETA (TLP-LL) TNR40-60 Recon 4mm Non-Locking Screw 60mm TNS25-28 Met FX Non-Locking Screw 2.5x28mm (Green) TLS20-10 Met FX Locking Screw 2x10mm (Magenta) (TNR27-34) 2.7 mm Non-Locking Screw 34 mm TNS20-22 Met FX Non-Locking Screw 2x22mm (Gold) (TNR27-30) 2.7 mm Non-Locking Screw 30 mm Recon Non-Locking Screw 3.5x46mm (TNR35-46) (TNR27-20) 2.7 mm Non-Locking Screw 20 mm Recon 2.7mm Non-Locking Screw 14mm (TNR27-14) TNR27-32 (TNR27-30) (TNR27-36) 2.7 mm Non-Locking Screw 36 mm Recon 2.7mm Non-Locking Screw 34mm (TNR27-34) Recon 2.7mm Non-Locking Screw 38mm (TNR27-38) Recon 2.7 mm Locking Screw 18 mm (TLR27-18) (TNR27-22) 2.7 mm Non-Locking Screw 22 mm (TNR27-28) 2.7 mm Non-Locking Screw 28 mm Recon 2.7 mm Locking Screw 10 mm (TLR27-10) Recon Locking Screw 3.5x42mm (TLR35-42) Recon Non-Locking Screw 3.5x38mm (TNR35-38) Recon MTP Plate Small 5D, 40mm Right (TMP40-5R) Recon Non-Locking Screw 3.5x36mm (TNR35-36) Recon 2.7mm Non-Locking Screw 50mm (TNR27-50) Recon Locking Screw 3.5x34mm (TLR35-34) Recon Locking Screw 3.5x48mm (TLR35-48) Recon 2.7mm Non-Locking Screw 20mm (TNR27-20)

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)