510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K213791Substantially Equivalent

Unispace SA Cervical Cage

Edisoninno Co., Ltd., Uijeongbu-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213791 is the FDA 510(k) clearance record for Unispace SA Cervical Cage, a class II device, cleared for Edisoninno Co., Ltd. on under FDA product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical). FDA's definition for product code OVE reads: "Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation". FDA records list one 510(k) clearance for Edisoninno Co., Ltd. As of , FDA records show no recalls naming K213791.

Clearance record

Decision date
Received
(242 days to decision)
Product code
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
Edisoninno Co., Ltd. 20, Sandan-Ro 76 Beon-Gil(Rd), Uijeongbu-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVE

Trailing 12 months
15 clearances under product code OVE in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code OVE, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20263
May 20260
June 20263
July 20262
August 20261
September 20262
October 20261