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

Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

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

OWW is the FDA product code for Mesh, Surgical, 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 during tendon repair procedures". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
OWW
Device name
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
FDA definition
For reinforcement of soft tissue where weakness exists during tendon repair procedures.
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
10
Ingested recalls
3

Clearances, product code OWW

By decision year
10 clearances under product code OWW with a decision year between 2012 and 2025, 2024 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OWW by decision year
YearClearances
20121
20161
20211
20232
20243
20252

Applicants with the most clearances

Product code OWW
Applicants holding the most 510(k) clearances under product code OWW
ApplicantClearances
Alafair Biosciences, Inc.3
ConMed Corporation2
Biorez, Inc.1
Celestray Biotech Company, LLC.1
International Life Sciences1
Nanofiber Solutions LLC1
Soft Tissue Regeneration, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order