NON CONSTRAINED TOTAL SHOULDER SYSTEM
FDA 510(k) clearance K895802 · decided 1989-12-27
Clearance details
- K-number
- K895802
- Device name
- NON CONSTRAINED TOTAL SHOULDER SYSTEM
- Applicant
- Orthopaedic Medical Group, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1989-09-28
- Decision date
- 1989-12-27
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KWT
- Device class
- 2
- Regulation number
- 888.3650
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.