510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052491Substantially Equivalent

Axya Model 6500 Axyaloop Self-Tapping Bone Anchor

TORNIER Inc., Beverly MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052491 is the FDA 510(k) clearance record for AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR, a class II device, cleared for Axya Medical, Inc. on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list 140 510(k) clearances for TORNIER Inc., from to . As of , FDA records show 21 recalls naming K052491.

Clearance record

Decision date
Received
(25 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Axya Medical, Inc. 100 Cummings Center,, Beverly MA
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