510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953961Substantially Equivalent

Osteonics Insight Knee Positioning & Alignment System

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

K953961 is the FDA 510(k) clearance record for OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM, a class I device, cleared for Osteonics Corp. on under FDA product code FWW (Table, Operating-Room, Pneumatic). FDA records list 178 510(k) clearances for Osteonics Corp., from to . As of , FDA records show no recalls naming K953961.

Clearance record

Decision date
Received
(99 days to decision)
Product code
FWW Table, Operating-Room, Pneumatic
Regulation
21 CFR 878.4960
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Osteonics Corp. 59 Rte. 17, Allendale NJ
510(k) summary
Summary
Third party review
No

Clearances, product code FWW

Trailing 12 months

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

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