510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191242Substantially Equivalent

HEALIX ADVANCE SP BIOCOMPOSITE Anchor

Medos International SARL, Le Locle, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191242 is the FDA 510(k) clearance record for HEALIX ADVANCE SP BIOCOMPOSITE Anchor, a class II device, cleared for Medos International SARL on under FDA product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue). FDA records list 101 510(k) clearances for Medos International SARL, from to . As of , FDA records show no recalls naming K191242.

Clearance record

Decision date
Received
(105 days to decision)
Product code
MAI Fastener, Fixation, Biodegradable, Soft Tissue
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Medos International SARL Chemin-Blanc 38, Case Postale, Le Locle, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAI

Trailing 12 months
5 clearances under product code MAI in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260