510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850352Substantially Equivalent

Micro-Struc. Acetabular Compon- Mc2p

Osteonics Corp., Allendale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850352 is the FDA 510(k) clearance record for MICRO-STRUC. ACETABULAR COMPON- MC2P, a class III device, cleared for Osteonics Corp. on under FDA product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)). FDA records list 178 510(k) clearances for Osteonics Corp., from to . As of , FDA records show no recalls naming K850352.

Clearance record

Decision date
Received
(87 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
Osteonics Corp. 59 Rte. 17, Allendale NJ
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDL, 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