K-WIRE 2.5MM X 230MM NO THREAD (44180230)

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: K100146

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

K-WIRE 2.5MM X 230MM NO THREAD (44180230) EVOLVE EPS CORT SCRW 2.7X28MMNON LOCKING (4942728N) EVOLVE®EPS CANCL SCRW 3.5X12MMNON LOCKING (4943512N) EVOLVE® EPS CORT SCRW 3.5X18MMNON LOCKING (4933518N) EVOLVEEPS CANCL SCRW 3.5X36MMPOLYAXIAL LOCKING (4943536L) EVOLVE EPS CORT SCRW 3.5X34MMPOLYAXIAL LOCKING (4933534L) EVOLVEEPS CANCL SCRW 3.5X24MMNON LOCKING (4943524N) EVOLVEEPS CANCL SCRW 3.5X20MMPOLYAXIAL LOCKING (4943520L) EVOLVE® EPS CORT SCRW 3.5X20MMNON LOCKING (4933520N) EVOLVE EPS CORT SCRW 3.5X16MMPOLYAXIAL LOCKING (4933516L) EVOLVE® EPS CORT SCRW 2.7X38MMPOLYAXIAL LOCKING (4942738L) EVOLVE EPS CORT SCRW 2.7X34MMNON LOCKING (4942734N) EVOLVE EPS CORT SCRW 2.7X30MMPOLYAXIAL LOCKING (4942730L) EVOLVE EPS CORT SCRW 2.7X14MMPOLYAXIAL LOCKING (4942714L) EVOLVEEPS CANCL SCRW 3.5X38MMPOLYAXIAL LOCKING (4943538L) EVOLVE EPS CORT SCRW 3.5X20MMPOLYAXIAL LOCKING (4933520L) EVOLVE®EPS CANCL SCRW 3.5X10MMNON LOCKING (4943510N) EVOLVE EPS CORT SCRW 2.7X18MMNON LOCKING (4942718N) EVOLVE® EPS CORT SCRW 2.7X10MMPOLYAXIAL LOCKING (4942710L) EVOLVE® EPS CORT SCRW 3.5X40MMPOLYAXIAL LOCKING (4933540L) EVOLVE EPS CORT SCRW 3.5X40MMNON LOCKING (4933540N) EVOLVE® EPS CORT SCRW 2.7X36MMPOLYAXIAL LOCKING (4942736L) EVOLVE EPS CORT SCRW 3.5X34MMNON LOCKING (4933534N) EVOLVE EPS CORT SCRW 2.7X28MMPOLYAXIAL LOCKING (4942728L) EVOLVE EPS CORT SCRW 3.5X36MMPOLYAXIAL LOCKING (4933536L) EVOLVE® EPS CORT SCRW 2.7X50MMNON LOCKING (4942750N) EVOLVE® EPS CORT SCRW 3.5X38MMNON LOCKING (4933538N) EVOLVE EPS CORT SCRW 2.7X10MMNON LOCKING (4942710N) EVOLVEEPS CANCL SCRW 3.5X22MMNON LOCKING (4943522N) EVOLVE® EPS CORT SCRW 2.7X45MMPOLYAXIAL LOCKING (4942745L) EVOLVE EPS CORT SCRW 3.5X24MMNON LOCKING (4933524N) EVOLVE®EPS CANCL SCRW 3.5X60MMLOCKING (4943560L) EVOLVE EPS CORT SCRW 3.5X12MMNON LOCKING (4933512N) EVOLVE EPS CORT SCRW 3.5X18MMPOLYAXIAL LOCKING (4933518L) EVOLVE EPS CORT SCRW 3.5X32MMPOLYAXIAL LOCKING (4933532L) EVOLVE EPS CORT SCRW 2.7X12MMPOLYAXIAL LOCKING (4942712L) EVOLVE EPS CORT SCRW 2.7X40MMPOLYAXIAL LOCKING (4942740L) EVOLVEEPS CANCL SCRW 3.5X45MMNON LOCKING (4943545N) EVOLVE® EPS CORT SCRW 2.7X18MMPOLYAXIAL LOCKING (4942718L) EVOLVEEPS CANCL SCRW 3.5X36MMNON LOCKING (4943536N) EVOLVE® EPS CORT SCRW 3.5X38MMPOLYAXIAL LOCKING (4933538L) EVOLVE EPS CORT SCRW 3.5X14MMPOLYAXIAL LOCKING (4933514L) EVOLVE® EPS CORT SCRW 2.7X20MMPOLYAXIAL LOCKING (4942720L) EVOLVE® EPS CORT SCRW 2.7X20MMNON LOCKING (4942720N) EVOLVE®EPS CANCL SCRW 3.5X60MMNON LOCKING (4943560N) EVOLVE®EPS CANCL SCRW 3.5X18MMPOLYAXIAL LOCKING (4943518L) EVOLVE EPS CORT SCRW 2.7X22MMNON LOCKING (4942722N) EVOLVE® EPS CORT SCRW 3.5X12MMPOLYAXIAL LOCKING (4933512L) EVOLVEEPS CANCL SCRW 3.5X50MMNON LOCKING (4943550N) EVOLVE EPS CORT SCRW 3.5X45MMNON LOCKING (4933545N) EVOLVE EPS CORT SCRW 3.5X50MMNON LOCKING (4933550N) EVOLVE EPS CORT SCRW 3.5X22MMPOLYAXIAL LOCKING (4933522L) EVOLVEEPS CANCL SCRW 3.5X14MMPOLYAXIAL LOCKING (4943514L) EVOLVE EPS CORT SCRW 3.5X30MMNON LOCKING (4933530N) EVOLVE® EPS CORT SCRW 2.7X24MMPOLYAXIAL LOCKING (4942724L) EVOLVE EPS CORT SCRW 2.7X40MMNON LOCKING (4942740N) EVOLVE® EPS CORT SCRW 2.7X26MMNON LOCKING (4942726N) EVOLVEEPS CANCL SCRW 3.5X34MMPOLYAXIAL LOCKING (4943534L) EVOLVE EPS CORT SCRW 2.7X26MMPOLYAXIAL LOCKING (4942726L) EVOLVE®EPS CANCL SCRW 3.5X24MMPOLYAXIAL LOCKING (4943524L) EVOLVE® EPS CORT SCRW 3.5X26MMPOLYAXIAL LOCKING (4933526L) EVOLVE EPS CORT SCRW 2.7X32MMPOLYAXIAL LOCKING (4942732L) EVOLVE® EPS CORT SCRW 2.7X38MMNON LOCKING (4942738N) EVOLVE®EPS CANCL SCRW 3.5X22MMPOLYAXIAL LOCKING (4943522L) EVOLVE®EPS CANCL SCRW 3.5X50MMPOLYAXIAL LOCKING (4943550L) EVOLVE® EPS CORT SCRW 3.5X24MMPOLYAXIAL LOCKING (4933524L) EVOLVE®EPS CANCL SCRW 3.5X55MMLOCKING (4943555L) EVOLVE EPS CORT SCRW 3.5X16MMNON LOCKING (4933516N) EVOLVE® EPS CORT SCRW 3.5X45MMPOLYAXIAL LOCKING (4933545L) EVOLVE EPS CORT SCRW 2.7X12MMNON LOCKING (4942712N) EVOLVE EPS CORT SCRW 2.7X16MMNON LOCKING (4942716N) EVOLVE EPS CORT SCRW 2.7X14MMNON LOCKING (4942714N) EVOLVE EPS CORT SCRW 3.5X22MMNON LOCKING (4933522N) EVOLVE®EPS CANCL SCRW 3.5X18MMNON LOCKING (4943518N) EVOLVEEPS CANCL SCRW 3.5X12MMPOLYAXIAL LOCKING (4943512L) EVOLVE EPS CORT SCRW 2.7X50MMPOLYAXIAL LOCKING (4942750L) EVOLVE® EPS CORT SCRW 3.5X32MMNON LOCKING (4933532N) EVOLVEEPS CANCL SCRW 3.5X20MMNON LOCKING (4943520N) EVOLVE®EPS CANCL SCRW 3.5X10MMPOLYAXIAL LOCKING (4943510L) EVOLVEEPS CANCL SCRW 3.5X26MMPOLYAXIAL LOCKING (4943526L) EVOLVE EPS CORT SCRW 3.5X36MMNON LOCKING (4933536N) EVOLVE EPS CORT SCRW 3.5X28MMNON LOCKING (4933528N) EVOLVEEPS CANCL SCRW 3.5X45MMPOLYAXIAL LOCKING (4943545L) EVOLVE®EPS CANCL SCRW 3.5X32MMNON LOCKING (4943532N) EVOLVE EPS CORT SCRW 2.7X16MMPOLYAXIAL LOCKING (4942716L) EVOLVE®EPS CANCL SCRW 3.5X26MMNON LOCKING (4943526N) EVOLVE EPS CORT SCRW 3.5X10MMNON LOCKING (4933510N) EVOLVEEPS CANCL SCRW 3.5X30MMNON LOCKING (4943530N) EVOLVEEPS CANCL SCRW 3.5X38MMNON LOCKING (4943538N) EVOLVE®EPS CANCL SCRW 3.5X14MMNON LOCKING (4943514N) EVOLVE EPS CORT SCRW 3.5X26MMNON LOCKING (4933526N) EVOLVEEPS CANCL SCRW 3.5X40MMNON LOCKING (4943540N) EVOLVEEPS CANCL SCRW 3.5X28MMNON LOCKING (4943528N) EVOLVEEPS CANCL SCRW 3.5X16MMNON LOCKING (4943516N) EVOLVEEPS CANCL SCRW 3.5X30MMPOLYAXIAL LOCKING (4943530L) EVOLVE EPS CORT SCRW 2.7X22MMPOLYAXIAL LOCKING (4942722L) EVOLVEEPS CANCL SCRW 3.5X34MMNON LOCKING (4943534N) EVOLVE®EPS CANCL SCRW 3.5X40MMPOLYAXIAL LOCKING (4943540L) EVOLVE EPS CORT SCRW 2.7X32MMNON LOCKING (4942732N) EVOLVE EPS CORT SCRW 3.5X10MMPOLYAXIAL LOCKING (4933510L) EVOLVEEPS CANCL SCRW 3.5X55MMNON LOCKING (4943555N) EVOLVE®EPS CANCL SCRW 3.5X28MMPOLYAXIAL LOCKING (4943528L) EVOLVE EPS CORT SCRW 2.7X36MMNON LOCKING (4942736N) EVOLVE®EPS CANCL SCRW 3.5X32MMPOLYAXIAL LOCKING (4943532L) EVOLVE® EPS CORT SCRW 2.7X30MMNON LOCKING (4942730N) EVOLVE® EPS CORT SCRW 3.5X28MMPOLYAXIAL LOCKING (4933528L) EVOLVE® EPS CORT SCRW 2.7X24MMNON LOCKING (4942724N) EVOLVE® EPS CORT SCRW 2.7X34MMPOLYAXIAL LOCKING (4942734L) EVOLVE EPS CORT SCRW 3.5X14MMNON LOCKING (4933514N) EVOLVEEPS CANCL SCRW 3.5X16MMPOLYAXIAL LOCKING (4943516L) EVOLVE® EPS CORT SCRW 3.5X30MMPOLYAXIAL LOCKING (4933530L) EVOLVE EPS CORT SCRW 3.5X50MMPOLYAXIAL LOCKING (4933550L) EVOLVE EPS CORT SCRW 2.7X45MMNON LOCKING (4942745N)

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)