LOCKING SCREW 3.5 X 14MM (58803514)

Registration Details

Registration Name: STRAITS ORTHOPAEDICS (MFG) SDN BHD
Registration Number: 3012217062
FEI Number: 3012217062
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: No 2483 Tingkat Perusahaan 4A, Prai Free Industrial Zone
City: Perai Pulau Pinang
Country: MY

Regulatory Submissions

510(k) Number: K102429

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	2020-07-21
Plate, Fixation, Bone	HRS	Class 2	Orthopedic	No	2020-07-21

Proprietary Names

LOCKING SCREW 3.5 X 14MM (58803514) LOCKING SCREW 3.5 X 30MM (58803530) LOCKING LG HD SCREW 2.7X16MM (58S02716) LOCKING SCREW 3.5X32MM (58S03532) LOCKING SCREW 3.5 X 42MM (58803542) LOCKING SCREW 3.5 X 38MM (58803538) LOCKING SCREW 3.5 X 60MM (58803560) LOCKING SCREW 3.5X30MM (58S03530) LOCKING SCREW 3.5 X 48MM (58803548) LOCKING SCREW 3.5 X 34MM (58803534) LOCKING LG HD SCREW 2.7X28MM (58802728) LOCKING LG HD SCREW 2.7X22MM (58S02722) LOCKING SCREW 3.5 X 54MM (58803554) LOCKING SCREW 3.5 X 18MM (58803518) LOCKING SCREW 3.5X44MM (58S03544) LOCKING SCREW 3.5 X 44MM (58803544) LOCKING LG HD SCREW 2.7X20MM (58802720) LOCKING LG HD SCREW 2.7X18MM (58S02718) LOCKING LG HD SCREW 2.7X24MM (58802724) LOCKING LG HD SCREW 2.7X26MM (58S02726) LOCKING LG HD SCREW 2.7X14MM (58802714) LOCKING LG HD SCREW 2.7X18MM (58802718) LOCKING SCREW 3.5 X 26MM (58803526) LOCKING SCREW 3.5X22MM (58S03522) LOCKING SCREW 3.5X50MM (58S03550) LOCKING LG HD SCREW 2.7X22MM (58802722) LOCKING SCREW 3.5 X 36MM (58803536) LOCKING SCREW 3.5X20MM (58S03520) LOCKING SCREW 3.5 X 22MM (58803522) LOCKING LG HD SCREW 2.7X14MM (58S02714) LOCKING SCREW 3.5 X 24MM (58803524) LOCKING LG HD SCREW 2.7X10MM (58802710) Cancellous Screw Full 4 X 18 Ortholoc Plating System (58934018) LOCKING SCREW 3.5X14MM (58S03514) LOCKING SCREW 3.5 X 46MM (58803546) Cortical Screw Full 3.5 X 26mm Ortholoc System (58913526) LOCKING SCREW 3.5X26MM (58S03526) LOCKING SCREW 3.5X16MM (58S03516) LOCKING SCREW 3.5 X 55MM (58803555) CORTICAL SCREW FULL 4X30MM (58924030) LOCKING SCREW 3.5 X 40MM (58803540) LOCKING SCREW 3.5 X 52MM (58803552) LOCKING LG HD SCREW 2.7X24MM (58S02724) Cancellous Screw Part 4 X 26 Ortholoc Plating System (58944026) LOCKING SCREW 3.5 X 16MM (58803516) Cancellous Screw Full 4 X 50 Ortholoc Plating System (58934050) LOCKING SCREW 3.5X24MM (58S03524) LOCKING LG HD SCREW 2.7X10MM (58S02710) Cortical Screw Full 3.5 X 44mm Ortholoc System (58913544) Cortical Screw Full 3.5 X 34mm Ortholoc System (58913534) LOCKING SCREW 3.5X46MM (58S03546) LOCKING SCREW 3.5X55MM (58S03555) LOCKING SCREW 3.5 X 32MM (58803532) Cancellous Screw Part 4 X 28 Ortholoc Plating System (58944028) LOCKING SCREW 3.5X34MM (58S03534) LOCKING SCREW 3.5 X 20MM (58803520) LOCKING SCREW 3.5 X 50MM (58803550) LOCKING SCREW 3.5 X 58MM (58803558) CORTICAL SCREW FULL 4X28MM (58924028) LOCKING LG HD SCREW 2.7X30MM (58S02730) LOCKING SCREW 3.5X60MM (58S03560) LOCKING SCREW 3.5X42MM (58S03542) LOCKING SCREW 3.5X18MM (58S03518) LOCKING SCREW 3.5X40MM (58S03540) LOCKING LG HD SCREW 2.7X12MM (58S02712) Cancellous Screw Full 4 X 40 Ortholoc Plating System (58934040) LOCKING LG HD SCREW 2.7X16MM (58802716) LOCKING LG HD SCREW 2.7X30MM (58802730) LOCKING LG HD SCREW 2.7X20MM (58S02720) LOCKING SCREW 3.5 X 28MM (58803528) LOCKING SCREW 3.5X10MM (58S03510) LOCKING LG HD SCREW 2.7X26MM (58802726) LOCKING SCREW 3.5 X 12MM (58803512) LOCKING SCREW 3.5X28MM (58S03528) Cortical Screw Full 3.5 X 24mm Ortholoc System (58913524) LOCKING SCREW 3.5X36MM (58S03536) LOCKING SCREW 3.5X48MM (58S03548) Cancellous Screw Full 4 X 30 Ortholoc Plating System (58934030) LOCKING SCREW 3.5 X 10MM (58803510) LOCKING SCREW 3.5X38MM (58S03538) LOCKING LG HD SCREW 2.7X12MM (58802712) Cancellous Screw Part 4 X 60 Ortholoc Plating System (58944060) Cancellous Screw Part 4 X 35 Ortholoc Plating System (58944035) Cancellous Screw Full 4 X 12 Ortholoc Plating System (58934012) CORTICAL SCREW FULL 4X42MM ORTHOLOC SYSTEM (58924042) LOCKING SCREW 3.5 X 56MM (58803556) LOCKING SCREW 3.5X12MM (58S03512) LOCKING LG HD SCREW 2.7X28MM (58S02728) CORTICAL SCREW FULL 4X40MM ORTHOLOC SYSTEM (58924040) Cancellous Screw Full 4 X 45 Ortholoc Plating System (58934045) Cortical Screw Full 3.5 X 12mm Ortholoc System (58913512) Cortical Screw Full 3.5 X 32mm Ortholoc System (58913532) Cortical Screw Full 3.5 X 46mm Ortholoc System (58913546) Cortical Screw Full 3.5 X 10mm Ortholoc System (58913510) Cancellous Screw Full 4 X 35 Ortholoc Plating System (58934035) Cortical Screw Full 3.5 X 14mm Ortholoc System (58913514) Cortical Screw Full 3.5 X 20mm Ortholoc System (58913520) Cortical Screw Full 3.5 X 36mm Ortholoc System (58913536) Cortical Screw Full 3.5 X 38mm Ortholoc System (58913538) Cortical Screw Full 3.5 X 42mm Ortholoc System (58913542) Cancellous Screw Full 4 X 20 Ortholoc Plating System (58934020) Cortical Screw Full 3.5 X 22mm Ortholoc System (58913522)

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)