COLUMBUS (PS)
FDA 510(k) clearance K030367 · decided 2003-08-21
Clearance details
- K-number
- K030367
- Device name
- COLUMBUS (PS)
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-04
- Decision date
- 2003-08-21
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.