510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K122336Substantially Equivalent

Q-Fix Suture Anchor, 1.8Mm Q-Fix Access Tools (Drill Guide W/obturator, Drill Bit) 1.8Mm

Eleven Blade Solutions, Inc., Los Gatos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122336 is the FDA 510(k) clearance record for Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM, a class II device, cleared for Eleven Blade Solutions, Inc. on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list one 510(k) clearance for Eleven Blade Solutions, Inc. As of , FDA records show no recalls naming K122336.

Clearance record

Decision date
Received
(160 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Eleven Blade Solutions, Inc. 14734 La Rinconada Dr., Los Gatos CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBI

Trailing 12 months
31 clearances under product code MBI in the twelve months to October 2026, March 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code MBI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20263
February 20261
March 20269
April 20261
May 20264
June 20261
July 20264
August 20262
September 20263
October 20260