Data / Medical devices / Costa Rica / Zimmer Biomet Centroamerica SA
Zimmer Biomet Centroamerica SA: FDA-registered device maker in san jose, Costa Rica, 18 510(k) clearances and 1 PMA approval
Zimmer Biomet Centroamerica SA is registered with the FDA (registration 3014315560) in san jose, Costa Rica. It lists 25 device types. The FDA files 18 510(k) clearances and 1 PMA approval under its listings, the newest dated February 8, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014315560
- Address
- Oficentro Ejecutivo La Sabana Edificio 7, Piso 3, san jose, Costa Rica, 10101
- Owner or operator
- ZimmerBiomet Americas DFE (10056779)
- Roles
- Exporter to the US
- First device listed
- January 22, 2018
- Registered through
- 2026
- Brand names listed
- ACE 3.5MM CORTICAL BONE SCREW, BIODRIVE CANNULATED SCREW SYSTEM, BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR, Comprehensive Segmental Revision System (SRS), EBI OPTILOCK PERIARTICULAR PLATING SYSTEM, EBI PERIARTICULAR PLATING SYSTEM, EBI TROCHANTERIC NAIL SYSTEM, FINE GRAIN CAST COBALT CHROMIUM HIP 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 8, 2018 | K173411 | Comprehensive Segmental Revision System (SRS) | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| June 16, 2016 | K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | MBB | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 2, 2014 | K140908 | JUGGERKNOT MINI SOFT ANCHOR | DZL | Substantially Equivalent | Biomet Sports Medicine | accessdata.fda.gov |
| December 23, 2013 | K132386 | TOTALSHIELD SURGICAL HELMET SYSTEM | FYA | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 12, 2012 | K111663 | TRAUMA INTERNAL FIXATION SYSTEMS | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 4, 2011 | K110145 | BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR | MBI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 5, 2009 | K082874 | BIODRIVE CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Biomet Trauma | accessdata.fda.gov |
| May 24, 2006 | K061098 | EBI OPTILOCK PERIARTICULAR PLATING SYSTEM | HRS | Substantially Equivalent | Ebi, L.P. | accessdata.fda.gov |
| February 16, 2005 | K050118 | EBI TROCHANTERIC NAIL SYSTEM | HSB | Substantially Equivalent | Ebi, L.P. | accessdata.fda.gov |
| October 1, 2004 | K042037 | M2A MAGNUM SYSTEM | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 16, 2004 | K042237 | EBI PERIARTICULAR PLATING SYSTEM | HRS | Substantially Equivalent | Ebi, L.P. | accessdata.fda.gov |
| April 22, 2004 | K040770 | VANGUARD PATELLA COMPONENTS | JWH | Substantially Equivalent | Biomet Manufacturing, Inc. | accessdata.fda.gov |
| April 11, 2000 | K990830 | MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 31, 1996 | K953925 | FINE GRAIN CAST COBALT CHROMIUM HIP STEMS | LZO | Substantially Equivalent for Some Indications | Biomet, Inc. | accessdata.fda.gov |
| April 6, 1994 | K940371 | SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP | KYZ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| June 30, 1992 | K920800 | INTEGRATED ENDOSCOPY SYSTEM 1000 | HRX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 30, 1991 | K905048 | ACE 3.5MM CORTICAL BONE SCREW | HWC | Substantially Equivalent | Ace Medical Co. | accessdata.fda.gov |
| August 17, 1987 | K871539 | ZINDRICK IM ROD | HSB | Substantially Equivalent | Buckman Co., 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 |
|---|---|---|---|---|---|---|
| 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 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Elbow, Constrained, Cemented
- All makers of Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Updated October 6, 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.