FDA Device Registration & Listing · Mexico City Ciudad de Mexico, MX · Registration 3006809628
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | Class 2 | 888.3360 | 2018-01-23 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2018-01-23 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2018-01-23 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-01-23 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2018-01-23 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | Orthopedic | Class 3 | 888.3320 | 2018-01-23 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2018-01-23 |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | Orthopedic | Class 2 | 888.3353 | 2018-01-23 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2018-01-23 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Orthopedic | Class 3 | 888.3330 | 2018-01-23 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2018-01-23 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2018-01-23 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | Orthopedic | Class 3 | 888.3320 | 2018-01-23 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-01-23 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | Class 2 | 888.3360 | 2018-01-23 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2018-01-23 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-01-23 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Orthopedic | Class 3 | 888.3330 | 2018-01-23 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2018-01-23 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2018-01-23 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2018-01-23 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2018-01-23 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2018-01-16 |
No official correspondent registered.
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3014315560 | Zimmer Biomet Centroamerica SA | san jose, CR |
| 3013086329 | WM WORLD MEDICAL IMPORTACAO E EXPORTACAO LTDA. | Rio de Janeiro, BR |
| 3014302784 | BIOMET CHILE S.A. | Santiago de Chile Region Metropolitana, CL |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K042344 | Aesculap, Inc. | EXCIA TOTAL HIP SYSTEM | 2005-03-16 |
| K860442 | Howmedica Corp. | PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259 | 1986-05-06 |
| K973124 | Sulzer Orthopedics, Inc. | APR POROUS HA HIP SYSTEM | 1997-11-03 |
| K823482 | Intermedics Orthopedics | 101 UNIVERSAL ENDOPROSTHESIS | 1983-02-07 |
| K854107 | Kirschner Medical Corp. | DIMENSION TOTAL HIP PROSTHESIS POROUS COATED | 1986-03-10 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0009-2007 | Smith & Nephew Inc | 1 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
| Z-0010-2007 | Smith & Nephew Inc | 1 | Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486 |
| Z-0011-06 | Stryker Howmedica Osteonics Corp. | 1 | Allocraft TLIF Bone Inserter. |
| Z-0011-2007 | Smith & Nephew Inc | 1 | Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105 |
| Z-0013-2011 | Depuy Orthopaedics, Inc. | 1 | Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143
Catalog Number: 2570-00-000
The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3005061536 | SYMMETRY MEDICAL MANUFACTURING INC | CLAYPOOL, IN, US |
| 3007923096 | Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, CN |
| 3006801265 | Zhejiang Biomet Medical Products Co., Ltd. | Jinhua Zhejiang, CN |
| 2134285 | RIVERSIDE MACHINE & ENGINEERING, INC. | Eau Claire, WI, US |
| 9614209 | Corin Limited | CIRENCESTER Gloucestershire, GB |
3006809628 when referencing this establishment in official correspondence.