510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K051821Substantially Equivalent

Inion S-1 Biodegradable Anterior Cervical Fusion System

Inion Oy, Tampere, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051821 is the FDA 510(k) clearance record for INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, a class II device, cleared for Inion , Ltd. on under FDA product code OJB (Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate). FDA's definition for product code OJB reads: "Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional...". FDA records list 37 510(k) clearances for Inion , Ltd., from to . As of , FDA records show no recalls naming K051821.

Clearance record

Decision date
Received
(143 days to decision)
Product code
OJB Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Inion , Ltd. Laakarinkatu 2, Tampere, FI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OJB

Trailing 12 months

FDA records hold no clearances under product code OJB in the trailing twelve months.

FDA records show no clearances under product code OJB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OJB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260