510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K122791Substantially Equivalent

Lyoplant Onlay

Aesculap Inc, Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122791 is the FDA 510(k) clearance record for LYOPLANT ONLAY, a class II device, cleared for Aesculap, Inc. on under FDA product code GXQ (Dura Substitute). FDA records list 269 510(k) clearances for Aesculap, Inc., from to . As of , FDA records show no recalls naming K122791.

Clearance record

Decision date
Received
(265 days to decision)
Product code
GXQ Dura Substitute
Regulation
21 CFR 882.5910
Device class
Class II
Review panel
Neurology
Applicant
Aesculap, Inc. 3773 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXQ

Trailing 12 months
1 clearance under product code GXQ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GXQ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260