510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964953Substantially Equivalent

In-Tac Bone Anchor System

Influence, Inc., North Potomac MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964953 is the FDA 510(k) clearance record for IN-TAC BONE ANCHOR SYSTEM, a class I device, cleared for Influence, Inc. on under FDA product code HXJ (Staple Driver). FDA records list 16 510(k) clearances for Influence, Inc., from to . As of , FDA records show no recalls naming K964953.

Clearance record

Decision date
Received
(70 days to decision)
Product code
HXJ Staple Driver
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Influence, Inc. 12307 Winesap Ter., North Potomac MD
510(k) summary
Summary
Third party review
No

Clearances, product code HXJ

Trailing 12 months

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

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