BIOFILL BONE VOID FILLER
FDA 510(k) clearance K040454 · decided 2004-05-07
Clearance details
- K-number
- K040454
- Device name
- BIOFILL BONE VOID FILLER
- Applicant
- Scient'X
- Decision
- Substantially Equivalent
- Date received
- 2004-02-23
- Decision date
- 2004-05-07
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Round Rock, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.