510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872858Substantially Equivalent

Williams Vertebral Spreader

Ace Medical, Martinez CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872858 is the FDA 510(k) clearance record for WILLIAMS VERTEBRAL SPREADER, a class I device, cleared for Ace Medical Co. on under FDA product code HXP (Instrument, Bending Or Contouring). FDA records list 22 510(k) clearances for Ace Medical Co., from to . As of , FDA records show no recalls naming K872858.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HXP Instrument, Bending Or Contouring
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Ace Medical Co. David W. Schlerf, Martinez CA
Third party review
No

Clearances, product code HXP

Trailing 12 months

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

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