510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K910229Substantially Equivalent

Soft Tissue Suture Washer/3 Hole Washer

Depuy, Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910229 is the FDA 510(k) clearance record for SOFT TISSUE SUTURE WASHER/3 HOLE WASHER, a class II device, cleared for Depuy, Inc. on under FDA product code HTN (Washer, Bolt Nut). FDA records list 220 510(k) clearances for Depuy, Inc., from to . As of , FDA records show no recalls naming K910229.

Clearance record

Decision date
Received
(187 days to decision)
Product code
HTN Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Depuy, Inc. P.O. Box 988, Warsaw IN
Third party review
No

Clearances, product code HTN

Trailing 12 months
3 clearances under product code HTN in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTN, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260