Data / Medical devices / Chile / Biomet Chile S.A.
Biomet Chile S.A.: FDA-registered device maker in Santiago de Chile Region Metropolitana, Chile, 133 510(k) clearances
Biomet Chile S.A. is registered with the FDA (registration 3014302784) in Santiago de Chile Region Metropolitana, Chile. It lists 62 device types. The FDA files 133 510(k) clearances 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
- 3014302784
- Address
- Av. Santa Clara No. 085 Floor 7 HUECHURABA, Santiago de Chile Region Metropolitana, Chile, 8580000
- Owner or operator
- ZimmerBiomet Americas DFE (10056779)
- Roles
- Exporter to the US
- First device listed
- January 16, 2018
- Registered through
- 2026
- Brand names listed
- 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL, 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES, 100KGY E-POLY MAXROM ACETABULAR LINERS, 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM, ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS, AGC TOTAL KNEE PROSTHESIS, ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS, ARCOS INTERLOCKING DISTAL STEMS 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 133.
| 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 |
| May 26, 2016 | K161190 | G7 Dual Mobility System, Active Articulation System | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 31, 2015 | K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw | HWC | Substantially Equivalent | Zimmer, 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 23, 2014 | K142933 | Biomet Tibial trays | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 28, 2014 | K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 14, 2014 | K140508 | ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 13, 2014 | K141734 | ZIMMER PERIARTICULAR LOCKING SYSTEM | HRS | 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 |
| April 1, 2014 | K133939 | MODIFIED DISTAL RADIUS PLATING SYSTEM | HRS | Substantially Equivalent | Biomet | accessdata.fda.gov |
| March 28, 2014 | K133940 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) | HRY | Substantially Equivalent | Biomet UK, Ltd. | accessdata.fda.gov |
| October 9, 2013 | K132704 | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW | LXT | Substantially Equivalent | Biomet | accessdata.fda.gov |
| August 30, 2013 | K130610 | SIRIUS FEMORAL STEM | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 3, 2013 | K131670 | LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 19, 2013 | K130063 | ARCOS TROCHANTER BUTTON | LPH | Substantially Equivalent | Biomet, 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 |
| February 27, 2013 | K123501 | OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 23, 2012 | K121874 | G7 ACETABULAR SYSTEM | PBI | Substantially Equivalent | Biomet Manufacturing Corp | 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 |
| May 16, 2012 | K121149 | VANGUARD SSK 360 REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| February 29, 2012 | K113550 | VANGUARD COMPLETE KNEE SYSTEM | JWH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| January 11, 2012 | K113069 | COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 15, 2011 | K112218 | ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS | KTT | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 15, 2011 | K111746 | COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) | KWT | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 31, 2011 | K112345 | DISTAL VOLAR RADIUS PLATING SYSTEMS | LXT | Substantially Equivalent | Medos International SARL | 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 |
| 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 |
| June 18, 2010 | K101475 | COMPRESS ANTI-ROTATION SPINDLES | KWA | Substantially Equivalent | Biomet Manufacturing Corp | 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 |
| April 30, 2010 | K093235 | RINGLOC + HYBRID ACETABULAR SYSTEM | 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 |
| September 25, 2009 | K090757 | BIOMET MODULAR FEMORAL REVISION SYSTEM | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 17, 2009 | K091976 | BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL | HSB | Substantially Equivalent | Biomet Trauma | accessdata.fda.gov |
| June 26, 2009 | K090877 | PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | 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 |
| December 18, 2008 | K082527 | ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 15, 2008 | K082446 | BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS | KWA | Substantially Equivalent | Biomet, Inc. | 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 11, 2008 | K080088 | BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS | HWC | Substantially Equivalent | Biomet Manufacturing, Inc. | accessdata.fda.gov |
| September 20, 2007 | K072161 | BIOMET FEMORAL LOCKING NAIL SYSTEM | HSB | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 13, 2007 | K071718 | TRILOGY LONGEVITY CONSTRAINED LINER | KWZ | 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 |
| February 27, 2007 | K063570 | BIOMET TIBIAL LOCKING NAIL SYSTEM | HSB | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| January 19, 2007 | K062998 | COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 11, 2006 | K060694 | MODULAR HYBRID GLENOID | KWS | 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 19, 2006 | K062494 | EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM | HRS | Substantially Equivalent | Ebi, L.P. | accessdata.fda.gov |
| June 12, 2006 | K060716 | VERSA-DIAL HUMERAL HEAD PROSTHESIS | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| May 30, 2006 | K060692 | COMPREHENSIVE PRIMARY SHOULDER STEMS | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| May 12, 2006 | K060040 | ZIMMER M/L TAPER HIP PROSTHESIS | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 26, 2006 | K060710 | UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS | HWC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 17, 2006 | K052089 | XR-SERIES BI-METRIC FEMORAL COMPONENTS | LPH | Substantially Equivalent | Biomet Manufacturing, Inc. | accessdata.fda.gov |
| February 15, 2006 | K060131 | OSS-BODIES PROXIMAL TIBIAL SLEEVE | KRO | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 6, 2005 | K052888 | POROUS TITANIUM ACETABULAR AUGMENTS | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 27, 2005 | K052685 | ORTHOPEDIC SALVAGE SYSTEM- OSS | KRO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 6, 2005 | K051975 | POROUS COATED DISCOVERY ELBOW | JDC | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 10, 2005 | K051479 | RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS | KRO | Substantially Equivalent | Biomet Manufacturing, Inc. | accessdata.fda.gov |
| August 5, 2005 | K051385 | EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE | KWI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 5, 2005 | K043547 | COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 3, 2005 | K051532 | COBALT G HV BONE CEMENT | LOD | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 27, 2005 | K051516 | TRABECULAR METAL REVISION SHELL LINERS | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 19, 2005 | K050210 | DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 29, 2005 | K051411 | ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS | LZO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 29, 2005 | K050441 | TAPER 2 POROUS FEMORAL STEM | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 26, 2005 | K050932 | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | LXT | Substantially Equivalent | Hand Innovations, Inc. | accessdata.fda.gov |
| February 11, 2005 | K042757 | VANGUARD SSK KNEE SYSTEM | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 9, 2005 | K043505 | DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM | KWT | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 14, 2005 | K043537 | TAPERLOC 12/14 TAPER FEMORAL COMPONENTS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 1, 2004 | K042093 | VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS | HRY | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 29, 2004 | K042598 | PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 7, 2004 | K042032 | MAESTRO TOTAL WRIST | JWJ | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 28, 2004 | K041274 | RESORBABLE INTERFERENCE SCREW | HWC | Substantially Equivalent | Arthrotek, Inc. | accessdata.fda.gov |
| June 7, 2004 | K041261 | FEMORAL HOOK | MBI | Substantially Equivalent | Arthrotek, Inc. | accessdata.fda.gov |
| February 2, 2004 | K033506 | COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE | KWS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 16, 2004 | K033363 | ZIMMER UNICOMPARTMENTAL KNEE SYSTEM | HSX | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 22, 2003 | K032726 | ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 22, 2003 | K031280 | ULTRA-DRIVE 3 | JDX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 6, 2003 | K031693 | MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 4, 2003 | K030710 | BIO-MODULAR SHOULDER SYSTEM | KWT | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 23, 2003 | K030047 | FREEDOM CONSTRAINED LINERS | KWZ | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 17, 2003 | K023546 | MAXIM ACCEL KNEE SYSTEM | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 13, 2002 | K023063 | COMPREHENSIVE HUMERAL FRACTURE SYSTEM | KWT | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| November 6, 2002 | K023357 | ARCPM 1050 RESIN-HIPS | LPH | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| June 26, 2002 | K021799 | CEMENTED FEMORAL HEAD RESURFING DEVICE | KXA | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| June 5, 2002 | K021621 | FIXED BEARING UNI COMPONENT | HRY | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 5, 2002 | K021260 | REDUCED SIZE ONCOLOGY SALVAGE SYSTEM | KRO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 30, 2002 | K020076 | PATRIOT PROTRUSIO CAGE | JDI | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| January 30, 2002 | K020045 | 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM | KWT | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| December 3, 2001 | K013657 | MODIFICATION TO: BIOMET HUMERAL CABLE PLATES | HRS | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| October 10, 2001 | K013042 | DISCOVERY ELBOW | JDC | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| July 18, 2001 | K011455 | BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 24, 2000 | K002757 | ONCOLOGY SALVAGE SYSTEM | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 24, 2000 | K001759 | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ | JDI | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| July 25, 2000 | K001989 | COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES | JDC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| June 23, 2000 | K000827 | UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED | KRR | Substantially Equivalent | Walter Abendschein, M.D. | accessdata.fda.gov |
| July 30, 1999 | K991581 | NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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.