Data / Medical devices / Singapore / Zimmer Pte. Ltd.
Zimmer Pte. Ltd.: FDA-registered device maker in Singapore South East, Singapore, 538 510(k) clearances and 1 PMA approval
Zimmer Pte. Ltd. is registered with the FDA (registration 3013176080) in Singapore South East, Singapore. It lists 82 device types. The FDA files 538 510(k) clearances and 1 PMA approval under its listings, the newest dated July 28, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013176080
- Address
- 401 Commonwealth Drive #06-03 How Par Techno Centre, Singapore South East, Singapore, 149598
- Owner or operator
- Zimmer Biomet APAC DFE (10056128)
- Roles
- Exporter to the US
- First device listed
- August 14, 2018
- Registered through
- 2026
- Brand names listed
- Biomet Knee Joint Replacement Prostheses, THE NATURAL-KNEE REVISION
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. Newest 100 of 538.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 28, 2017 | K171054 | Biomet Knee Joint Replacement Prostheses | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 4, 2015 | K150768 | JuggerKnot Soft Anchors | MBI | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 1, 2015 | K150889 | Suture Wires and Wire Loops | JDQ | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 1, 2015 | K150818 | Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System | KTT | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 10, 2015 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 29, 2014 | K142746 | G7 Finned Acetabular Shell | LPH | Substantially Equivalent | Biomet Manufactuting Corp. | accessdata.fda.gov |
| October 22, 2014 | K142579 | Zimmer Periarticular Plating System | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 22, 2014 | K142281 | ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM | HSB | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 24, 2013 | K131393 | MAK OSS FEMORAL KNEE COMPONENTS | KRO | Substantially Equivalent | Biomet Orthopedics Corp. | accessdata.fda.gov |
| October 8, 2013 | K131353 | COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 6, 2013 | K132239 | COMPREHENSIVE REVERSE SHOULDER SCREWS | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| March 18, 2013 | K123485 | JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF | MBI | Substantially Equivalent | Biomet Sports Medicine | accessdata.fda.gov |
| September 14, 2012 | K113296 | ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| June 26, 2012 | K113383 | XTRAFIX EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | Extraortho, Inc. | accessdata.fda.gov |
| March 12, 2012 | K111663 | TRAUMA INTERNAL FIXATION SYSTEMS | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 29, 2012 | K113550 | VANGUARD COMPLETE KNEE SYSTEM | JWH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| February 16, 2012 | K120121 | COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE | PHX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 11, 2012 | K113069 | COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 16, 2011 | K113121 | COMPREHENSIVE REVERSE SHOULDER | PHX | Substantially Equivalent | Biomet Manufacturing, Inc. | accessdata.fda.gov |
| February 17, 2011 | K103001 | ROCKWOOD CLAVICLE PINS | JDW | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 7, 2010 | K100469 | ARCOS INTERLOCKING DISTAL STEMS | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 27, 2009 | K092150 | COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT | LOD | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 11, 2009 | K091799 | CABLE READY CABLE GRIP SYSTEM CABLE BUTTON | HTN | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 6, 2009 | K090994 | LIGAFIX INTERFACE SCREW | HWC | Substantially Equivalent | Science For Biomaterials | accessdata.fda.gov |
| April 3, 2009 | K083779 | MAK OSS KNEE FEMORAL COMPONENTS | KRO | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| March 25, 2009 | K090473 | DISCOVERY ELBOW - X-SMALL | JDC | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| March 23, 2009 | K083789 | ACE FISCHER EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 20, 2009 | K083843 | LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 11, 2009 | K090374 | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S | LXT | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 26, 2009 | K083654 | ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 18, 2009 | K082300 | ANATOMIC LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 13, 2009 | K083827 | ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES | KRO | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| February 11, 2009 | K090103 | 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL | MAY | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 5, 2009 | K082874 | BIODRIVE CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Biomet Trauma | accessdata.fda.gov |
| December 18, 2008 | K082527 | ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 11, 2008 | K083364 | 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 11, 2008 | K082770 | ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL | HSB | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 3, 2008 | K082078 | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 31, 2008 | K080979 | STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT | KWY | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 16, 2008 | K081759 | NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V | HRS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| October 15, 2008 | K082446 | BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 26, 2008 | K081860 | ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 9, 2008 | K082293 | SURGVIEW INTEGRATED VISUALIZATION SYSTEM | HRX | Substantially Equivalent | Biovision Technologies, LLC | accessdata.fda.gov |
| August 26, 2008 | K081546 | SMALL BONE LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 7, 2008 | K073499 | VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES | JDL | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 30, 2008 | K081244 | LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS | KTT | Substantially Equivalent | Biomet Trauma | accessdata.fda.gov |
| July 29, 2008 | K080426 | MAESTRO WRIST FRACTURE IMPLANT | JWJ | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 9, 2008 | K080642 | COMPREHENSIVE REVERSE SHOULDER | PHX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 20, 2008 | K073316 | CERAMENT BONE VOID FILLER, MODEL A0210 | MQV | Substantially Equivalent | Bonesupport AB | accessdata.fda.gov |
| June 11, 2008 | K080330 | SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER | KRO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 21, 2008 | K080361 | REGENEREX TIBIAL COMPONENTS | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 20, 2008 | K080204 | VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 13, 2008 | K073567 | BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| March 7, 2008 | K073286 | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 7, 2008 | K071723 | ZIMMER POROLOCK MIS STEM | KWA | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| February 8, 2008 | K073347 | DYNESYS TOP-LOADING SPINAL SYSTEM | NQP | Unknown | Zimmer Spine, Inc. | accessdata.fda.gov |
| January 14, 2008 | K072879 | INNERVUE DIAGNOSTIC SCOPE SYSTEM | HRX | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| January 7, 2008 | K072121 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER | KWZ | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 6, 2007 | K072330 | CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM | FMF | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 27, 2007 | K073102 | BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS | LZO | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| November 21, 2007 | K072619 | NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 7, 2007 | K072423 | 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 5, 2007 | K072336 | REGENEREX POROUS TITANIUM SLEEVE AUGMENTS | JWH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 25, 2007 | K072083 | SMALL FRAGMENT LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 12, 2007 | K070955 | ACID ETCHED LAG SCREWS | HSB | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| September 6, 2007 | K072281 | NEXGEN PROLONG ALL-POLY PATELLA | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 5, 2007 | K072160 | NEXGEN TRABECULAR METAL TIBIAL TRAY | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 9, 2007 | K070389 | PEEK KNOTLESS ANCHORS | HWC | Substantially Equivalent | Biomet Sports Medicine, Inc. | accessdata.fda.gov |
| July 30, 2007 | K071856 | ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES | KWA | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 13, 2007 | K071718 | TRILOGY LONGEVITY CONSTRAINED LINER | KWZ | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 9, 2007 | K071395 | BIOMET VISION FOOTRING SYSTEM | KTT | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 3, 2007 | K070978 | ZIMMER SEGMENTAL SYSTEM | KRO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 2, 2007 | K071569 | ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER | MBI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 29, 2007 | K071090 | TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION | KWS | Substantially Equivalent | Zimmer Trabecular Metal Technology | accessdata.fda.gov |
| June 29, 2007 | K071053 | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD | KXA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 7, 2007 | K070695 | ZIMMER PATELLOFEMORAL JOINT PROSTHESIS | KRR | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 4, 2007 | K070399 | 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES | JDI | Substantially Equivalent | Biomet Manufacturing, Inc. | accessdata.fda.gov |
| May 3, 2007 | K070364 | 100KGY E-POLY MAXROM ACETABULAR LINERS | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 1, 2007 | K070906 | MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS | HWC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 26, 2007 | K070292 | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS | KXA | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| March 29, 2007 | K070507 | MODIFICATION TO: LIGAFIX INTERFERENCE SCREW | HWC | Substantially Equivalent | Science For Biomaterials | accessdata.fda.gov |
| March 16, 2007 | K070214 | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 9, 2007 | K070369 | REGENERX RINGLOC + MODULAR ACETABULAR SHELLS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 9, 2007 | K063778 | FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE | GAT | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| February 2, 2007 | K063515 | TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE | HRY | Substantially Equivalent | Biomet Manufacturing, Inc. | accessdata.fda.gov |
| January 24, 2007 | K063251 | ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY | KWA | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 18, 2007 | K063732 | MICROPLASTY TIBIAL TRAYS | JWH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| January 4, 2007 | K063509 | DEPUY PEAK FX HIP PLATE | KTT | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 20, 2006 | K061461 | MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05 | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 11, 2006 | K060694 | MODULAR HYBRID GLENOID | KWS | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 8, 2006 | K062997 | ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS | LZO | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| November 22, 2006 | K063303 | UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 31, 2006 | K063002 | ALTRA PRESS-FIT HIP SYSTEM | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 19, 2006 | K062494 | EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM | HRS | Substantially Equivalent | Ebi, L.P. | accessdata.fda.gov |
| October 19, 2006 | K062352 | FRS SCREW | HWC | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 19, 2006 | K061681 | REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT | HRY | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 13, 2006 | K062768 | NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 2, 2006 | K061226 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 25, 2006 | K061657 | HITCH LACTOSORB SUTURE ANCHOR | JDR | Substantially Equivalent | Arthrotek, Inc. | accessdata.fda.gov |
| July 24, 2006 | K061786 | VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 17, 1976 | N17755 | ZIMMER(R) BONE CEMENT | LOD | 26 | October 28, 1997 | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Staple, Fixation, Bone
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Updated July 28, 2017. 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.