Data / Medical devices / South Korea / Zimmer Biomet Korea Ltd.
Zimmer Biomet Korea Ltd.: FDA-registered device maker in Seoul, South Korea, 629 510(k) clearances and 2 PMA approvals
Zimmer Biomet Korea Ltd. is registered with the FDA (registration 3015542154) in Seoul, South Korea. It lists 108 device types. The FDA files 629 510(k) clearances and 2 PMA approvals under its listings, the newest dated October 4, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015542154
- Address
- 5F, Ilshin Building, 98 Hannamdae-ro, Yongsan-gu, Seoul, South Korea, 04418
- Owner or operator
- Zimmer Biomet APAC DFE (10056128)
- Roles
- Exporter to the US
- First device listed
- April 5, 2018
- Registered through
- 2027
- Brand names listed
- A. L. P. S. Clavicle Plating System, AFX® Femoral Implant with Inserter, ALLthread Titanium Suture Anchor, ANA0TOMICAL SHOULDER TM COMBINED SYSTEM, BENDER, BIOMET CEMENT; MIXER, BIOMET DEPTH; GAUGE; Gauge Biomet Depth, BIOMET FILE 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. Newest 100 of 629.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 4, 2022 | K221928 | ROSA® Knee System | OLO | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| December 10, 2021 | K212435 | Comprehensive Humeral Fracture Positioning Sleeves | KWS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 19, 2021 | K210121 | ROSA Partial Knee System | OLO | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| December 8, 2020 | K200196 | Taperloc® Complete Hip Stems | LZO | Substantially Equivalent | Biomet Orthopedics | accessdata.fda.gov |
| October 28, 2020 | K193038 | Comprehensive Shoulder System | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 16, 2020 | K191449 | ZCA All-Poly Acetabular Cups | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 9, 2020 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 15, 2020 | K193373 | Comprehensive® Reverse Shoulder | PHX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 24, 2020 | K193451 | Titanium Interference Screws | HWC | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 16, 2020 | K192942 | ALLthread Titanium Suture Anchor | MBI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 5, 2019 | K192428 | AFX Femoral Implant with Inserter | MBI | Substantially Equivalent | Cayenne Medical | accessdata.fda.gov |
| September 13, 2019 | K191459 | JuggerStitch Meniscal Repair Device | MBI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 24, 2019 | K190789 | IntelliCartTM System | JCX | Substantially Equivalent | Dornoch Medical Systems | accessdata.fda.gov |
| January 28, 2019 | K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | JDC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 24, 2018 | K181611 | Comprehensive Reverse Shoulder System | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| April 6, 2018 | K173767 | A. L. P. S. Clavicle Plating System | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 29, 2018 | K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 30, 2017 | K172767 | Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid | PHX | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 28, 2017 | K171054 | Biomet Knee Joint Replacement Prostheses | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 3, 2016 | K161592 | Persona Partial Knee System | HSX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 10, 2016 | K153657 | Vanguard XP Knee System | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 9, 2016 | K160058 | Biomet Variable Pitch Compression Screw System | HWC | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 15, 2016 | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System | JDQ | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 30, 2015 | K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables | KTT | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 25, 2015 | K152494 | Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments | JWH | Substantially Equivalent | Zimmer, 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 |
| March 30, 2015 | K143697 | Biomet Proximal Humerus Plating System | HRS | Substantially Equivalent | Biomet Manufacturing | accessdata.fda.gov |
| March 4, 2015 | K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS | HRS | 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 |
| November 12, 2014 | K142836 | Zimmer Plates and Screws (ZPS), Forte Screws | HRS | Substantially Equivalent | Zimmer, Inc. | 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 |
| July 30, 2014 | K140883 | VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 11, 2013 | K132873 | VANGUARD XP KNEE SYSTEM | MBH | Substantially Equivalent | Biomet, 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 |
| August 9, 2013 | K123553 | ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM | KCY | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 1, 2013 | K130033 | TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO | MBI | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| May 9, 2013 | K130661 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Zimmer, Inc. | 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 |
| November 23, 2012 | K121874 | G7 ACETABULAR SYSTEM | PBI | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 31, 2012 | K122314 | QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY | MBI | Substantially Equivalent | Cayenne Medical, Inc. | 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 |
| August 17, 2012 | K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | LPH | Substantially Equivalent | Biomet Manufacturing Corp | 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 17, 2012 | K112814 | CUFFINK | MBI | Substantially Equivalent | Cayenne Medical, 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 |
| September 30, 2011 | K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| March 24, 2011 | K110054 | NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE | OLO | Substantially Equivalent | Zimmer Cas | accessdata.fda.gov |
| March 15, 2011 | K103404 | ANA0TOMICAL SHOULDER TM COMBINED SYSTEM | KWT | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| February 17, 2011 | K103001 | ROCKWOOD CLAVICLE PINS | JDW | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 15, 2011 | K103517 | TRABECULAR METAL FEMORAL CONE AUGMENTS | MBH | Substantially Equivalent | Zimmer Trabecular Metal Technology, Inc. | accessdata.fda.gov |
| January 21, 2011 | K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| January 10, 2011 | K103033 | TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX | ODP | Substantially Equivalent | Zimmer Trabecular Metal Technology | accessdata.fda.gov |
| December 13, 2010 | K102896 | TRABECULAR METAL TIBIAL CONE AUGMENTS | MBH | Substantially Equivalent | Zimmer Trabecular Metal Technology | accessdata.fda.gov |
| December 7, 2010 | K100469 | ARCOS INTERLOCKING DISTAL STEMS | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 3, 2010 | K101229 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 22, 2010 | K093293 | VANGUARD 360 REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 1, 2010 | K101622 | ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS | HSB | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 10, 2010 | K101696 | MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM | HWC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 3, 2010 | K101086 | TAPERLOC COMPLETE | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 28, 2010 | K093561 | ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 5, 2010 | K100599 | CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM | OLO | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
| February 4, 2010 | K093846 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 28, 2009 | K091566 | ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS | HSB | Substantially Equivalent | Zimmer GmbH | 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 25, 2009 | K090757 | BIOMET MODULAR FEMORAL REVISION SYSTEM | KWA | 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 |
| September 11, 2009 | K091508 | ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM | LPH | 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 19, 2009 | K083497 | ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS | HSB | 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 |
| January 15, 2009 | K082996 | BIOLOX DELTA OPTION CERAMIC HEADS | LZO | Substantially Equivalent | Biomet, Inc. | 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 |
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 |
|---|---|---|---|---|---|---|
| December 10, 2007 | P060037 | NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM | NJL | 98 | October 16, 2026 | accessdata.fda.gov |
| 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, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- All makers of Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Updated October 16, 2026. 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.