510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895607Substantially Equivalent for Some Indications

Porous Coated Total Hip Pros. Acetabular Component

Exactech, Inc., Gainesville FL / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K895607 is the FDA 510(k) clearance record for POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT, a class III device, cleared for Exactech, Inc. on under FDA product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)). FDA records list 186 510(k) clearances for Exactech, Inc., from to . As of , FDA records show no recalls naming K895607.

Clearance record

Decision date
Received
(60 days to decision)
Product code
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Regulation
21 CFR 888.3320
Device class
Class III
Review panel
Orthopedic
Applicant
Exactech, Inc. 4613 NW 6th St., Suite D, Gainesville FL
Third party review
No

Clearances, product code JDL

Trailing 12 months

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

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