BONE BLOCK FIXATION SET
FDA 510(k) clearance K050515 · decided 2005-04-05
Clearance details
- K-number
- K050515
- Device name
- BONE BLOCK FIXATION SET
- Applicant
- Straumann USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-01
- Decision date
- 2005-04-05
- Days to decision
- 35 days
- Clearance type
- Special
- Product code
- DZL
- Device class
- 2
- Regulation number
- 872.4880
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.