Signature ONE System
FDA 510(k) clearance K192074 · decided 2019-08-30
Clearance details
- K-number
- K192074
- Device name
- Signature ONE System
- Applicant
- Orthosoft Inc (D/B/A Zimmer Cas)
- Decision
- Substantially Equivalent
- Date received
- 2019-08-02
- Decision date
- 2019-08-30
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- QHE
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Montreal, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.