510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851339Substantially Equivalent

Precision Harvest & Inlay Instrument Set

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

K851339 is the FDA 510(k) clearance record for PRECISION HARVEST & INLAY INSTRUMENT SET, a class I device, cleared for Concept, Inc. on under FDA product code HWK (Trephine). FDA records list 83 510(k) clearances for Concept, Inc., from to . As of , FDA records show no recalls naming K851339.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HWK Trephine
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Concept, Inc. 12707 u.s. 19 S., Clearwater FL
Third party review
No

Clearances, product code HWK

Trailing 12 months

FDA records hold no clearances under product code HWK in the trailing twelve months.

FDA records show no clearances under product code HWK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HWK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260