510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954682Substantially Equivalent for Some Indications

Washer, Bolt, Nut, Orthopedic

Linvatec Corporation, Largo FL / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K954682 is the FDA 510(k) clearance record for WASHER, BOLT, NUT, ORTHOPEDIC, a class II device, cleared for Linvatec Corp. on under FDA product code HTN (Washer, Bolt Nut). FDA records list 93 510(k) clearances for Linvatec Corp., from to . As of , FDA records show no recalls naming K954682.

Clearance record

Decision date
Received
(121 days to decision)
Product code
HTN Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Linvatec Corp. 11311 Concept Blvd., Largo FL
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