Barricaid Instrument Tray
FDA 510(k) clearance K201676 · decided 2020-07-16
Clearance details
- K-number
- K201676
- Device name
- Barricaid Instrument Tray
- Applicant
- Intrinsic Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-06-19
- Decision date
- 2020-07-16
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- QHG
- Device class
- 2
- Regulation number
- 888.4510
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.