510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042295Substantially Equivalent

Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020

Linvatec Biomaterials, Ltd., Tampere, FI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042295 is the FDA 510(k) clearance record for SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020, a class II device, cleared for Linvatec Biomaterials, Ltd. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 8 510(k) clearances for Linvatec Biomaterials, Ltd., from to . As of , FDA records show no recalls naming K042295.

Clearance record

Decision date
Received
(23 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Linvatec Biomaterials, Ltd. Hermiankatu 6-8l, Tampere, FI
510(k) summary
Summary PDF
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