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510(k) K222220

SpinMedix Absorbable Fibrous Membrane by Celestray Biotech Company, LLC., — Product Code OWW

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.

Other clearances by Celestray Biotech Company, LLC.,

  • K230794 — Rebuilder Nerve Guidance Conduit (January 29, 2024)

Other clearances for product code OWW

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  • K250021 — Rotium (February 27, 2025)
  • K242187 — BioBrace® (November 27, 2024)
  • K241906 — BioBrace® Reinforced Implant (July 29, 2024)
  • K240817 — VersaWrap (June 14, 2024)
  • K230316 — FlexBand; FlexPatch; FlexBand Plus (May 26, 2023)
  • K203267 — The BioBrace Implant (April 30, 2021)
  • K160364 — VersaWrap Tendon Protector (June 10, 2016)
  • K121216 — STR GRAFT (November 21, 2012)