Data / Medical devices / Netherlands / Biomet Global Supply Chain Center B.V.
Biomet Global Supply Chain Center B.V.: FDA-registered device maker in Hazeldonk Noord-Brabant, Netherlands, 162 510(k) clearances and 4 PMA approvals
Biomet Global Supply Chain Center B.V. is registered with the FDA (registration 3013055499) in Hazeldonk Noord-Brabant, Netherlands. It lists 102 device types. The FDA files 162 510(k) clearances and 4 PMA approvals under its listings, the newest dated April 18, 2025. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3013055499
- Address
- 4836 LD Breda, Hazeldonk Noord-Brabant, Netherlands, 6530
- Owner or operator
- ZIMMER GMBH (9064978)
- Roles
- Exporter to the US
- First device listed
- April 8, 1996
- Registered through
- 2027
- Brand names listed
- 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY, 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM, 6.5MM SOLID CANCELLOUS BONE SCREW, A. L. P. S. Clavicle Plating System, ABBOTT SPINE UNIVERSAL CLAMP SYSTEM, ACE 3.5MM CORTICAL BONE SCREW, ACE AIM TTC FUSION NAIL, ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM 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 162.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 18, 2025 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | LZO | Substantially Equivalent | Zimmer Biomet | accessdata.fda.gov |
| July 29, 2020 | K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling | LZO | Substantially Equivalent | Biomet UK, Ltd. | accessdata.fda.gov |
| July 9, 2020 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 28, 2020 | K200814 | Affixus(R) Natural Nail(R) System Humeral Nail | HSB | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| April 10, 2020 | K200112 | Zimmer Hip Joint Replacement | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| February 27, 2020 | K192683 | Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads | LZO | Substantially Equivalent | Biomet UK, Ltd. | accessdata.fda.gov |
| January 29, 2020 | K193099 | Anatomical Shoulder System | PHX | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| December 26, 2019 | K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| December 18, 2019 | K192189 | Avenir Complete Hip System, Size 0 Coxa Vara | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 6, 2019 | K193030 | Avenir Muller Stem, Avenir Cemented Hip Stem | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| November 5, 2019 | K192236 | Fitmore Hip Stem | KWY | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| November 5, 2019 | K183457 | Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 11, 2019 | K192312 | Zimmer Natural Nail System Cephalomedullary Nails | HSB | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| October 1, 2019 | K192416 | BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| September 13, 2019 | K192217 | NCB Plating System Distal Femur and Proximal Tibia | HRS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| August 22, 2019 | K192021 | NCB Polyaxial Locking Plate System | HRS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| August 6, 2019 | K191781 | Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| April 2, 2019 | K181171 | Zimmer Biomet Ceramic Heads | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 26, 2018 | K181761 | Zimmer Biomet Select Ceramic Heads | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 14, 2018 | K181827 | Affixus Natural Nail System Humeral Nail | HSB | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| December 7, 2018 | K182048 | Avenir Complete Hip System | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 17, 2018 | K172524 | Zimmer Persona Personalized Knee System | MBH | Substantially Equivalent | Zimmer, Inc. | 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 |
| December 18, 2017 | K171858 | Sidus Stem-Free Shoulder | PKC | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| October 5, 2017 | K172408 | Biomet Bone Cement R | LOD | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 30, 2017 | K171540 | Refobacin Bone Cement R | LOD | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 1, 2017 | K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System | PHX | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| May 16, 2017 | K162133 | VerteFIT Corpectomy Cage System | MQP | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| February 7, 2017 | K170072 | Fitmore® Hip Stem | KWY | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| November 3, 2016 | K161592 | Persona Partial Knee System | HSX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 28, 2016 | K161173 | Avenue® T TLIF Cage | OVD | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| August 4, 2016 | K161798 | FacetBRIDGE® System | MRW | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| March 31, 2016 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System | MAX | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| January 25, 2016 | K152137 | FacetBRIDGE System | MRW | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| December 7, 2015 | K151934 | ROI-C Titanium-Coated Implant System | OVE | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| May 20, 2015 | K150090 | Zimmer Persona Personalized Knee System | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 1, 2015 | K150522 | G7 Dual Mobility System | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 30, 2015 | K143697 | Biomet Proximal Humerus Plating System | HRS | Substantially Equivalent | Biomet Manufacturing | 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 |
| December 11, 2014 | K140669 | G7 OSSEOTI ACETUBLAR SHELLS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 18, 2014 | K141653 | BIOLOX DELTA CERAMIC OPTION HEADS | LZO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 7, 2014 | K133363 | INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM | PEK | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| October 10, 2013 | K131684 | BIOLOX(R) DELTA CERAMIC HEADS | LZO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 22, 2013 | K123459 | ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 1, 2013 | K123134 | EASYSPINE SYSTEM | NKB | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| November 23, 2012 | K121874 | G7 ACETABULAR SYSTEM | PBI | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| November 7, 2012 | K121771 | ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 24, 2012 | K121103 | LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S | NKB | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| August 17, 2012 | K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | LPH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 26, 2012 | K113285 | LDR SPINE USA AVENUE L INTERBODY FUSION | OVD | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| June 27, 2012 | K120760 | LDR SPINE SPINETUNE TL SPINAL SYSTEM | MNH | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| March 27, 2012 | K113369 | ZIMMER PERSONA KNEE SYSTEM | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 12, 2012 | K111663 | TRAUMA INTERNAL FIXATION SYSTEMS | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 29, 2011 | K113559 | LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS | ODP | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| September 30, 2011 | K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 30, 2011 | K110327 | LDR SPINE ROI-A INTERBODY FUSION SYSTEM | OVD | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| August 26, 2011 | K111301 | INSTINCT JAVA SYSTEM | NKB | Substantially Equivalent | Zimmer Spine | accessdata.fda.gov |
| August 11, 2011 | K110348 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | OWI | Substantially Equivalent | Zimmer Spine | accessdata.fda.gov |
| June 22, 2011 | K111444 | UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION | HSB | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 13, 2011 | K110449 | ENDOBON XENOGRAFT GRANULES | LYC | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| January 21, 2011 | K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 7, 2010 | K100469 | ARCOS INTERLOCKING DISTAL STEMS | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 22, 2010 | K093293 | VANGUARD 360 REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 15, 2010 | K102331 | LDR SPINE USA SPINETUNE TL SPINAL SYSTEM | MNI | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| September 29, 2010 | K102265 | LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| September 3, 2010 | K101086 | TAPERLOC COMPLETE | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 23, 2010 | K101240 | CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 11, 2010 | K100238 | HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM | HSB | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 31, 2010 | K100575 | LDR SPINE USA SPINE TUNE TL SPINE SYSTEM | MNI | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| December 16, 2009 | K093549 | 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM | LZO | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 14, 2009 | K091088 | LDR SPINE CERVICAL INTERBODY FUSION SYSTEM | ODP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| June 25, 2009 | K090507 | MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM | MAX | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| May 6, 2009 | K090994 | LIGAFIX INTERFACE SCREW | HWC | Substantially Equivalent | Science For Biomaterials | accessdata.fda.gov |
| March 20, 2009 | K083843 | LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 18, 2009 | K082300 | ANATOMIC LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 12, 2009 | K083857 | LDR SPINE ROI-C IMPLANT | MQP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| February 2, 2009 | K082262 | LDR SPINE ROI INTERBODY FUSION SYSTEM | MAX | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| January 15, 2009 | K082996 | BIOLOX DELTA OPTION CERAMIC HEADS | LZO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 8, 2008 | K082592 | LDR SPINE EASYSPINE SYSTEM | NKB | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| August 26, 2008 | K081546 | SMALL BONE LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 15, 2008 | K080685 | HIPLOC COMPRESSION HIP SCREW | JDO | Substantially Equivalent | Biomet Manufacturing, Inc. | accessdata.fda.gov |
| April 7, 2008 | K080572 | LDR SPINE ROI-A IMPLANT | MQP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| March 7, 2008 | K071723 | ZIMMER POROLOCK MIS STEM | KWA | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| December 14, 2007 | K072832 | ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, 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 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 |
| October 25, 2007 | K072083 | SMALL FRAGMENT LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 8, 2007 | K070341 | LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM | KWP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| March 29, 2007 | K070507 | MODIFICATION TO: LIGAFIX INTERFERENCE SCREW | HWC | Substantially Equivalent | Science For Biomaterials | accessdata.fda.gov |
| October 19, 2006 | K062352 | FRS SCREW | HWC | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 2, 2006 | K061226 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| June 6, 2006 | K061312 | 36MM BIOLOX DELTA CERAMIC HEADS | LZO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 30, 2006 | K060692 | COMPREHENSIVE PRIMARY SHOULDER STEMS | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| May 25, 2006 | K060746 | MEMORY STAPLE | JDR | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 12, 2006 | K060969 | POLYAX LOCKED PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 28, 2006 | K060370 | NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 6, 2006 | K060009 | ABBOTT SPINE UNIVERSAL CLAMP SYSTEM | JDQ | Substantially Equivalent | Abbott Spine, Inc. | accessdata.fda.gov |
| July 19, 2005 | K051623 | ANATOMICAL SHOULDER KEELED GLENOID | KWS | Substantially Equivalent | Zimmer GmbH | 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 |
|---|---|---|---|---|---|---|
| August 23, 2013 | P110009 | MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) | MJO | 34 | September 16, 2026 | accessdata.fda.gov |
| August 7, 2013 | P110002 | MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) | MJO | 34 | September 16, 2026 | accessdata.fda.gov |
| December 10, 2007 | P060037 | NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM | NJL | 98 | October 16, 2026 | accessdata.fda.gov |
| April 21, 2004 | P010014 | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM | NRA | 107 | October 6, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Surgical Table Cushion
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal
- All makers of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Updated September 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.