Data / Medical devices / Mexico / Biomet Mexico
Biomet Mexico: FDA-registered device maker in Mexico City Ciudad de Mexico, Mexico, 6 510(k) clearances
Biomet Mexico is registered with the FDA (registration 3006809628) in Mexico City Ciudad de Mexico, Mexico. It lists 15 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 17, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006809628
- Address
- Torre Jade Av. Periferico Sur No. 4829 401. Col Parques del Pedregal, Mexico City Ciudad de Mexico, Mexico, 14010
- Owner or operator
- ZimmerBiomet Americas DFE (10056779)
- Roles
- Exporter to the US
- First device listed
- January 16, 2018
- Registered through
- 2026
- Brand names listed
- Extractor, FEMORAL HOOK, MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS, TAPERLOC COMPLETE, TAPERLOC COMPLETE MICROPLASTY STEM, TAPERLOC COMPLETE SIZE 4MM AND XR 123, TAPERLOC COMPLETE, SIZE 5 AND 6, orthopedic manual surgical instrument
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 17, 2012 | K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | LPH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 30, 2011 | K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| January 21, 2011 | K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 3, 2010 | K101086 | TAPERLOC COMPLETE | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 7, 2004 | K041261 | FEMORAL HOOK | MBI | Substantially Equivalent | Arthrotek, Inc. | accessdata.fda.gov |
| August 11, 2003 | K030055 | MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal
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- All makers of Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Updated August 17, 2012. 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.