510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K952766Substantially Equivalent for Some Indications

Rayhack Osteotomy System (Modification)

Creative Medical Designs, Inc., Tampa FL / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K952766 is the FDA 510(k) clearance record for RAYHACK OSTEOTOMY SYSTEM (MODIFICATION), a class II device, cleared for Creative Medical Designs, Inc. on under FDA product code HRS (Plate, Fixation, Bone). FDA records list 2 510(k) clearances for Creative Medical Designs, Inc., from to . As of , FDA records show no recalls naming K952766.

Clearance record

Decision date
Received
(196 days to decision)
Product code
HRS Plate, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Creative Medical Designs, Inc. 13914 Shady Shores Dr., Tampa FL
Third party review
No

Clearances, product code HRS

Trailing 12 months
59 clearances under product code HRS in the twelve months to October 2026, March 2026 the highest month at 13.
Show the numbers
Monthly 510(k) clearances under FDA product code HRS, trailing twelve months
MonthClearances
November 20255
December 20255
January 20264
February 20265
March 202613
April 20266
May 20262
June 20265
July 20265
August 20263
September 20265
October 20261