AUSTIN-MOORE MODULAR HIP PROSTHESIS
FDA 510(k) clearance K845025 · decided 1985-04-19
Clearance details
- K-number
- K845025
- Device name
- AUSTIN-MOORE MODULAR HIP PROSTHESIS
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-27
- Decision date
- 1985-04-19
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- KWL
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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| COPAL® exchange G hip spacer; COPAL® G+V (K234028) | Heraeus Medical GmbH | 2024-02-15 |
| UHR Bipolar Implants, Restoration GAP II Implants (K222632) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-10-21 |
| OsteoRemedies Hip Spacer System (K192995) | Osteoremedies, LLC | 2020-01-10 |
| REMEDY Acetabular Cup (K191981) | Osteoremedies, LLC | 2019-08-23 |
| REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (K172906) | Osteoremedies, LLC | 2018-08-29 |
| Remedy Acetabular Cup (K173967) | Osteoremedies, LLC | 2018-02-22 |
| Evolve UniPolar Head (K143184) | Signature Orthopaedics Pty, Ltd. | 2015-03-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009) | Biomet, Inc. | 2011-02-11 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S004) | Biomet, Inc. | 2009-04-17 |
| C2A TAPER ACETABULAR SYSTEM (P050009/S007) | Biomet, Inc. | 2009-03-13 |
| C2-A TAPER ACETABULAR SYSTEM (P050009/S005) | Biomet, Inc. | 2007-11-30 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S002) | Biomet, Inc. | 2006-06-16 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S001) | Biomet, Inc. | 2006-02-01 |
| C2 A-TAPER ACETABULAR SYSTEM (P050009) | Biomet, Inc. | 2005-12-16 |