510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013131Substantially Equivalent

Bioscrew Xtralok

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

K013131 is the FDA 510(k) clearance record for BIOSCREW XTRALOK, 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 one recall naming K013131.

Clearance record

Decision date
Received
(265 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
Summary
Third party review
No

Clearances, product code HWC

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