510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OWYClass II

Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

OWY is the FDA product code for Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "For reinforcement of soft tissue where weakness exists in tendon repair". As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OWY
Device name
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
FDA definition
For reinforcement of soft tissue where weakness exists in tendon repair.
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
0

Clearances, product code OWY

By decision year
14 clearances under product code OWY with a decision year between 2012 and 2025, 2025 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code OWY by decision year
YearClearances
20121
20132
20141
20161
20201
20211
20221
20231
20241
20254

Applicants with the most clearances

Product code OWY
Applicants holding the most 510(k) clearances under product code OWY
ApplicantClearances
Embody, Inc.4
Smith & Nephew, Inc.2
Arthrex GmbH1
Fibralign Corporation1
Kensey Nash Corporation dba Dsm Biomedical1
Kerecis Limited1
Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics1
Rotation Medical, Inc.1
Tybr Health, Inc.1
Wrightmedicaltechnologyinc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order