510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926547Substantially Equivalent

Mednext 1000 Bone Dissecting System

Mednext, Inc., West Point Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926547 is the FDA 510(k) clearance record for MEDNEXT 1000 BONE DISSECTING SYSTEM, a class I device, cleared for Mednext, Inc. on under FDA product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment). FDA records list 7 510(k) clearances for Mednext, Inc., from to . As of , FDA records show no recalls naming K926547.

Clearance record

Decision date
Received
(203 days to decision)
Product code
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Mednext, Inc. 3878 Prospect Ave., Suite 24, West Point Beach FL
510(k) summary
Summary
Third party review
No

Clearances, product code HSZ

Trailing 12 months

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

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