POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
FDA 510(k) clearance K041382 · decided 2005-06-17
Clearance details
- K-number
- K041382
- Device name
- POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
- Applicant
- Osteobiologics, Inc.
- Decision
- Unknown
- Date received
- 2004-05-25
- Decision date
- 2005-06-17
- Days to decision
- 388 days
- Clearance type
- Traditional
- Product code
- JDK
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.