510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160428Substantially Equivalent

Certex Spinal Fixation System

Xtant Medical Holdings, Inc., Miamisburg OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160428 is the FDA 510(k) clearance record for Certex Spinal Fixation System, a class II device, cleared for X-Spine Systems, Inc. on under FDA product code NKG (Posterior Cervical Screw System). FDA's definition for product code NKG reads: "Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4)...". FDA records list 40 510(k) clearances for Xtant Medical Holdings, Inc., from to . As of , FDA records show no recalls naming K160428.

Clearance record

Decision date
Received
(79 days to decision)
Product code
NKG Posterior Cervical Screw System
Regulation
21 CFR 888.3075
Device class
Class II
Review panel
Orthopedic
Applicant
X-Spine Systems, Inc. 452 Alexandersville Rd., Miamisburg OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NKG

Trailing 12 months
5 clearances under product code NKG in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NKG, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260