Cleared Traditional

SpinMedix Absorbable Fibrous Membrane

K222220 · Celestray Biotech Company, LLC., · Orthopedic

Jul 2023

Decision

346d

Days

Class 2

Risk

About This 510(k) Submission

K222220 is an FDA 510(k) clearance for the SpinMedix Absorbable Fibrous Membrane, a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWW), submitted by Celestray Biotech Company, LLC., (Bethesda, US). The FDA issued a Cleared decision on July 6, 2023, 346 days after receiving the submission on July 25, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K222220 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2022
Decision Date	July 06, 2023
Days to Decision	346 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWW — Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures.