510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K970400Substantially Equivalent

Bone Source Hydroxyapatite

Orthofix SRL, Richardson TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970400 is the FDA 510(k) clearance record for BONE SOURCE HYDROXYAPATITE, a class II device, cleared for Orthofix, Inc. on under FDA product code LZK (Implant, Malar). FDA records list 102 510(k) clearances for Orthofix, Inc., from to . As of , FDA records show no recalls naming K970400.

Clearance record

Decision date
Received
(88 days to decision)
Product code
LZK Implant, Malar
Regulation
21 CFR 878.3550
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Orthofix, Inc. 250 E. Arapaho Rd., Richardson TX
510(k) summary
Summary
Third party review
No

Clearances, product code LZK

Trailing 12 months

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

FDA records show no clearances under product code LZK in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LZK, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260