510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961725Substantially Equivalent

Oscar Orthosonics System for Cemented Arthroplasty Revision

C.L. Mcintosh & Assoc., Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961725 is the FDA 510(k) clearance record for OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION, a class II device, cleared for C.L. Mcintosh & Assoc., Inc. on under FDA product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment). FDA records list 4 510(k) clearances for C.L. Mcintosh & Assoc., Inc., from to . As of , FDA records show no recalls naming K961725.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JDX Instrument, Surgical, Sonic And Accessory/Attachment
Regulation
21 CFR 888.4580
Device class
Class II
Review panel
Orthopedic
Applicant
C.L. Mcintosh & Assoc., Inc. 12300 Twinbrook Pkwy., Suite 625, Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code JDX

Trailing 12 months

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

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