510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912640Substantially Equivalent

Concept Endosteal Fixation Device

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

K912640 is the FDA 510(k) clearance record for CONCEPT ENDOSTEAL FIXATION DEVICE, a class II device, cleared for Concept, Inc. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 83 510(k) clearances for Concept, Inc., from to . As of , FDA records show no recalls naming K912640.

Clearance record

Decision date
Received
(322 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Concept, Inc. 11311 Concept Blvd., Largo FL
510(k) summary
Statement
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