510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874961Substantially Equivalent

Bone Cutting Instruments & Accessories

Solway, Inc., Hollywood FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874961 is the FDA 510(k) clearance record for BONE CUTTING INSTRUMENTS & ACCESSORIES, a class I device, cleared for Solway, Inc. on under FDA product code GDR (Saw, Manual And Accessories). FDA records list 13 510(k) clearances for Solway, Inc., from to . As of , FDA records show no recalls naming K874961.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GDR Saw, Manual And Accessories
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Solway, Inc. Post Office Box 7647, Hollywood FL
Third party review
No

Clearances, product code GDR

Trailing 12 months

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

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