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
K934321Substantially Equivalent

Linvatec Stasys-Pes Fixation Device

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

K934321 is the FDA 510(k) clearance record for LINVATEC STASYS-PES FIXATION DEVICE, a class II device, cleared for Linvatec Corp. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 93 510(k) clearances for Linvatec Corp., from to . As of , FDA records show no recalls naming K934321.

Clearance record

Decision date
Received
(614 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Linvatec Corp. 11311 Concept Blvd., Largo FL
510(k) summary
Statement
Third party review
No

Clearances, product code HWC

Trailing 12 months
22 clearances under product code HWC in the twelve months to November 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code HWC, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20262
April 20263
May 20264
June 20262
July 20261
August 20263
September 20264
October 20262
November 20260