MAESTRO WRIST FRACTURE IMPLANT
FDA 510(k) clearance K080426 · decided 2008-07-29
Clearance details
- K-number
- K080426
- Device name
- MAESTRO WRIST FRACTURE IMPLANT
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2008-02-20
- Decision date
- 2008-07-29
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- JWJ
- Device class
- 2
- Regulation number
- 888.3800
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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| KinematX Total Wrist Arthroplasty System (K191525) | Extremity Medical, LLC | 2020-03-04 |
| INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM (K132250) | Integra LifeSciences Corporation | 2014-03-24 |
| MAESTRO TOTAL WRIST (K042032) | Biomet, Inc. | 2004-10-07 |
| BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST (K031203) | DePuy Orthopaedics, Inc. | 2003-07-14 |
| UNIVERSAL TOTAL WRIST SYSTEM (K030037) | Kinetikos Medical, Inc. | 2003-02-05 |
| WRIST IMPLANT (K021859) | Avanta Orthopaedics, Inc. | 2002-12-02 |
| MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM (K020554) | Kinetikos Medical, Inc. | 2002-05-03 |
| PASCO MIC AND MIC/ID PANELS/ CEFDINIR (K982156) | Pasco Laboratories, Inc. | 1998-07-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Oxford Knee System (P010014/S111) | Biomet Manufacturing Corp | 2025-08-07 |
| Oxford Partial Knee System (P010014/S109) | Biomet Manufacturing Corp | 2025-08-07 |
| OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S110) | Biomet Manufacturing Corp | 2025-06-24 |
| Oxford® Partial Knee System (P010014/S107) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Cementless Partial Knee System (P010014/S105) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Partial Knee System (P010014/S108) | Biomet Manufacturing Corp | 2024-11-18 |
| Oxford® Partial Knee System (P010014/S106) | Biomet Manufacturing Corp | 2024-08-19 |
| Oxford Partial Knee (P010014/S104) | Biomet Manufacturing Corp | 2023-04-06 |