510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K093093Substantially Equivalent

Small Plateau Spacer System

Life Spine, Hoffman Estates IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093093 is the FDA 510(k) clearance record for SMALL PLATEAU SPACER SYSTEM, a class II device, cleared for Life Spine 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 123 510(k) clearances for Life Spine, from to . As of , FDA records show no recalls naming K093093.

Clearance record

Decision date
Received
(377 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
Life Spine 2401 W. Hassell Rd., Hoffman Estates IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODP

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