510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951510Substantially Equivalent

Ace Bone Screw Tacking Kit

Ace Surgical Supply Co., Inc., Brockton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951510 is the FDA 510(k) clearance record for ACE BONE SCREW TACKING KIT, a class II device, cleared for Ace Surgical Supply Co., Inc. on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list 23 510(k) clearances for Ace Surgical Supply Co., Inc., from to . As of , FDA records show no recalls naming K951510.

Clearance record

Decision date
Received
(144 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Ace Surgical Supply Co., Inc. 1034 Pearl St., Brockton MA
510(k) summary
Statement
Third party review
No

Clearances, product code DZL

Trailing 12 months
1 clearance under product code DZL in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260