PAVLIK HARNESS
FDA 510(k) clearance K780375 · decided 1978-03-15
Clearance details
- K-number
- K780375
- Device name
- PAVLIK HARNESS
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-08
- Decision date
- 1978-03-15
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- IOZ
- Device class
- 1
- Regulation number
- 890.3665
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ABDUCTION PILLOW (K830243) | Warm & Form, Orthopedic Materials | 1983-03-08 |
| ABDUCTION PILLOW (K823820) | Danek Medical, Inc. | 1983-01-14 |
| HIP ABDUCTION SPLINT (K810557) | Orthomedics | 1981-03-13 |
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 |