Data / Medical devices / Malaysia / Smith and Nephew Operations Sdn. Bhd
Smith and Nephew Operations Sdn. Bhd: FDA-registered device maker in Penang Pulau Pinang, Malaysia, 29 510(k) clearances
Smith and Nephew Operations Sdn. Bhd is registered with the FDA (registration 3022142628) in Penang Pulau Pinang, Malaysia. It lists 23 device types. The FDA files 29 510(k) clearances under its listings, the newest dated August 22, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3022142628
- Address
- PMT 797, Persiaran Cassia Selatan 8 Taman Perindustrian Batu Kawan, Bandar Cassia, Penang Pulau Pinang, Malaysia, 14110
- Owner or operator
- Smith & Nephew, Inc. (1020279)
- Roles
- Manufacturer
- First device listed
- February 9, 2008
- Registered through
- 2027
- Brand names listed
- 4MM CANNULATED CAPTURED SCREW 32MM Stainless Steel, 4MM CANNULATED CAPTURED SCREW 34MM Stainless Stee, 4MM CANNULATED CAPTURED SCREW 38MM Stainless Steel, 4MM CANNULATED CAPTURED SCREW 42MM Stainless Steel, 4MM CANNULATED CAPTURED SCREW 44MM Stainless Steel, 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 30MM, 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 32MM, 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 34MM and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 22, 2024 | K241804 | TRIGEN INTERTAN 10S Nail System | JDS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 4, 2023 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 14, 2022 | K210980 | Smith & Nephew Intramedullary Nail Systems | HSB | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 29, 2022 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws | JDO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 1, 2022 | K211176 | Smith & Nephew Hip Systems | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 29, 2021 | K210837 | Smith & Nephew Plates and Screws | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 27, 2021 | K203405 | EVOS Large Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 16, 2020 | K201918 | EVOS Large Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 23, 2017 | K172262 | EVOS Small Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 11, 2017 | K170648 | ANTHEM CR Total Knee System | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 24, 2017 | K170887 | EVOS Small Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 18, 2016 | K162078 | EVOS Small Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 22, 2014 | K142807 | ANTHEM PS Total Knee System | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 7, 2014 | K140814 | EVOS MINI-FRAGMENT PLATING SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 27, 2012 | K113848 | R3 XLPE LINERS | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 26, 2010 | K093363 | COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 3, 2009 | K092386 | R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 19, 2007 | K071071 | CROSSLINKED POLYETHYLENE ARTICULAR INSERTS | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 6, 2007 | K070756 | SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 6, 2006 | K061019 | TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS | JDS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 3, 2006 | K060742 | LEGION COBALT CHROME REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 30, 2005 | K051557 | TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS | JDS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 11, 2005 | K041825 | SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 20, 2004 | K040212 | TRIGEN INTERTAN | JDS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 21, 2003 | K032295 | GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 2, 2002 | K022902 | SMITH & NEPHEW HIP SYSTEM | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 27, 1997 | K963509 | GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON | LPH | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
| August 2, 1996 | K962137 | GENESIS II CONSTRAINED SYSTEM | JWH | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
| August 22, 1995 | K951987 | GENESIS II TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Nail, Fixation, Bone
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Updated August 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.