510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970957Substantially Equivalent

Osteonics Restoration Acetabular Ring

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

K970957 is the FDA 510(k) clearance record for OSTEONICS RESTORATION ACETABULAR RING, a class II device, cleared for Osteonics Corp. on under FDA product code JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis). FDA records list 178 510(k) clearances for Osteonics Corp., from to . As of , FDA records show no recalls naming K970957.

Clearance record

Decision date
Received
(78 days to decision)
Product code
JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Osteonics Corp. 59 Rte. 17, Allendale NJ
510(k) summary
Summary
Third party review
No

Clearances, product code JDJ

Trailing 12 months

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

FDA records show no clearances under product code JDJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDJ, 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