ANSER Clavicle Pin
FDA 510(k) clearance K201830 · decided 2020-08-27
Clearance details
- K-number
- K201830
- Device name
- ANSER Clavicle Pin
- Applicant
- BAAT Medical Products B.V.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-02
- Decision date
- 2020-08-27
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rj Hengelo, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.