510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151104Substantially Equivalent

Otelo Ll

Spineart SA, Geneva, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151104 is the FDA 510(k) clearance record for OTELO LL, a class I device, cleared for Spineart on under FDA product code GAD (Retractor). FDA records list 57 510(k) clearances for Spineart, from to . As of , FDA records show no recalls naming K151104.

Clearance record

Decision date
Received
(257 days to decision)
Product code
GAD Retractor
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Spineart International Center Cointrin, Geneva, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAD

Trailing 12 months

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

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