Tecomet Global Unite Short Stem Instrumentation
FDA 510(k) clearance K211553 · decided 2021-08-04
Clearance details
- K-number
- K211553
- Device name
- Tecomet Global Unite Short Stem Instrumentation
- Applicant
- Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-05-19
- Decision date
- 2021-08-04
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.