FDA.reportPublic FDA data

510(k) K222220

Device
SpinMedix Absorbable Fibrous Membrane
Applicant
Celestray Biotech Company, LLC.,
510(k) number
K222220
Product code
OWW
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-06
Date received
2022-07-25
Regulation
878.3300
Classification name
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Charles C Han
Address
P.O. Box 341754 Bethesda MD US 20827 20827

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OWW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)Alafair Biosciences2025-07-18
K250021RotiumNanofiber Solutions, LLC2025-02-27
K242187BioBrace®Conmed Corporation2024-11-27
K241906BioBrace® Reinforced ImplantConmed Corporation2024-07-29
K240817VersaWrapAlafair Biosciences, Inc.2024-06-14
K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences2023-05-26
K203267The BioBrace ImplantBiorez, Inc.2021-04-30
K160364VersaWrap Tendon ProtectorAlafair Biosciences, Inc.2016-06-10
K121216STR GRAFTSoft Tissue Regeneration, Inc.2012-11-21