True Tulip, True M.I.S.
FDA 510(k) clearance K220297 · decided 2022-09-16
Clearance details
- K-number
- K220297
- Device name
- True Tulip, True M.I.S.
- Applicant
- Innovative Surgical Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-02-02
- Decision date
- 2022-09-16
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.