RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS
FDA 510(k) clearance K061955 · decided 2006-08-04
Clearance details
- K-number
- K061955
- Device name
- RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS
- Applicant
- Creative Medical Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-11
- Decision date
- 2006-08-04
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Tampa, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.