510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892655Substantially Equivalent

Acl Drill Guide System

Baxter Healthcare Corporation, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892655 is the FDA 510(k) clearance record for ACL DRILL GUIDE SYSTEM, a class I device, cleared for Baxter Healthcare Corp on under FDA product code LXI (Guide, Drill, Ligament). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K892655.

Clearance record

Decision date
Received
(168 days to decision)
Product code
LXI Guide, Drill, Ligament
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Baxter Healthcare Corp P O Box 11150, Santa Ana CA
Third party review
No

Clearances, product code LXI

Trailing 12 months

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

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