510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002790Substantially Equivalent

Add-on Condyle

Biomet Microfixation, Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002790 is the FDA 510(k) clearance record for ADD-ON CONDYLE, a class II device, cleared for Walter Lorenz Surgical, Inc. on under FDA product code NEI (Prosthesis, Condyle, Mandibular, Temporary). FDA records list 86 510(k) clearances for BIOMET MICROFIXATION, from to . As of , FDA records show no recalls naming K002790.

Clearance record

Decision date
Received
(333 days to decision)
Product code
NEI Prosthesis, Condyle, Mandibular, Temporary
Regulation
21 CFR 872.4770
Device class
Class II
Review panel
Dental
Applicant
Walter Lorenz Surgical, Inc. 11520 Tradeport Dr., Jacksonville FL
510(k) summary
Summary
Third party review
No

Clearances, product code NEI

Trailing 12 months

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

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