510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100305Substantially Equivalent

Eturn Spinal Implant Model Eturn Xx-12; Eturn Xx-16 Where Xx=07, 09, 11, 13, or 15 and Eturn Xx-12 K; Eturn Xx-16 K Wher

Icotec AG, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100305 is the FDA 510(k) clearance record for ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER, a class II device, cleared for Icotec on under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar). FDA's definition for product code MAX reads: "Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". FDA records list 17 510(k) clearances for Icotec, from to . As of , FDA records show no recalls naming K100305.

Clearance record

Decision date
Received
(533 days to decision)
Product code
MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
Icotec 4050 Olson Memorial Hwy., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAX

Trailing 12 months
19 clearances under product code MAX in the twelve months to October 2026, May 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code MAX, trailing twelve months
MonthClearances
November 20251
December 20251
January 20262
February 20263
March 20260
April 20261
May 20265
June 20261
July 20264
August 20261
September 20260
October 20260