Signature™ ONE System
FDA 510(k) clearance K232425 · decided 2023-12-12
Clearance details
- K-number
- K232425
- Device name
- Signature™ ONE System
- Applicant
- Orthosoft Inc. (D/B/A) Zimmer Cas)
- Decision
- Substantially Equivalent
- Date received
- 2023-08-11
- Decision date
- 2023-12-12
- Days to decision
- 123 days
- Clearance type
- Traditional
- 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.