510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180401Substantially Equivalent

TiWAVE-C™ Porous Titanium Cervical Cage

Kalitec Direct, LLC, Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180401 is the FDA 510(k) clearance record for TiWAVE-C™ Porous Titanium Cervical Cage, a class II device, cleared for Kalitec Direct, LLC on under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical). FDA's definition for product code ODP reads: "Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". FDA records list 9 510(k) clearances for Kalitec Direct, LLC, from to . As of , FDA records show no recalls naming K180401.

Clearance record

Decision date
Received
(120 days to decision)
Product code
ODP Intervertebral Fusion Device With Bone Graft, Cervical
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
Kalitec Direct, LLC 618 E. S. St., Suite 500, Orlando FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODP

Trailing 12 months
24 clearances under product code ODP in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code ODP, trailing twelve months
MonthClearances
November 20253
December 20252
January 20265
February 20261
March 20262
April 20264
May 20262
June 20260
July 20263
August 20262
September 20260
October 20260