POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
FDA 510(k) clearance K040047 · decided 2004-12-17
Clearance details
- K-number
- K040047
- Device name
- POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
- Applicant
- Osteobiologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-12
- Decision date
- 2004-12-17
- Days to decision
- 340 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as steril recall (Z-0440-2007) | Smith & Nephew, Inc. Endoscopy Division | 2006-12-30 |