510(k) K222220
K222220 is an FDA 510(k) premarket notification submitted by Celestray Biotech Company, LLC., for the device "SpinMedix Absorbable Fibrous Membrane". The FDA issued a decision of Substantially Equivalent on July 6, 2023. The device falls under product code OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300. Celestray Biotech Company, LLC., has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 2023
- Date Received
- July 25, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type
For reinforcement of soft tissue where weakness exists during tendon repair procedures.