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

Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

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

OWX is the FDA product code for Mesh, Surgical, Non-Absorbable, 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 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OWX
Device name
Mesh, Surgical, Non-Absorbable, 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
5
Ingested recalls
0

Clearances, product code OWX

By decision year
5 clearances under product code OWX with a decision year between 2023 and 2026, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OWX by decision year
YearClearances
20231
20241
20252
20261

Applicants with the most clearances

Product code OWX
Applicants holding the most 510(k) clearances under product code OWX
ApplicantClearances
Anika Therapeutics, Inc.2
Zurimed Technologies AG2
Arthrex GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order