GRAFTON PLUS DBM PASTE
FDA 510(k) clearance K043048 · decided 2005-11-23
Clearance details
- K-number
- K043048
- Device name
- GRAFTON PLUS DBM PASTE
- Applicant
- Osteotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-04
- Decision date
- 2005-11-23
- Days to decision
- 384 days
- Clearance type
- Traditional
- Product code
- MBP
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Eatontown, NJ, US
- Third-party review
- No
- Expedited review
- No
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