510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K053655Substantially Equivalent

Tendon Wrap Tendon Protector

Integra LifeSciences Corporation, Planisboro NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053655 is the FDA 510(k) clearance record for TENDON WRAP TENDON PROTECTOR, a class II device, cleared for Integra LifeSciences Corporation on under FDA product code FTM (Mesh, Surgical). FDA records list 94 510(k) clearances for Integra LifeSciences Corporation, from to . As of , FDA records show no recalls naming K053655.

Clearance record

Decision date
Received
(35 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Integra LifeSciences Corporation 311 Enterprise Dr., Planisboro NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTM

Trailing 12 months
1 clearance under product code FTM in the twelve months to November 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260