510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123932Substantially Equivalent

Zygafix Spinal Facet Screw System

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

K123932 is the FDA 510(k) clearance record for ZYGAFIX SPINAL FACET SCREW SYSTEM, cleared for X-Spine Systems, Inc. on under FDA product code MRW (System, Facet Screw Spinal Device). FDA records list 40 510(k) clearances for Xtant Medical Holdings, Inc., from to . As of , FDA records show no recalls naming K123932.

Clearance record

Decision date
Received
(132 days to decision)
Product code
MRW System, Facet Screw Spinal Device
Device class
Unclassified
Review panel
Unknown
Applicant
X-Spine Systems, Inc. 452 Alexandersville Rd., Miamisburg OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRW

Trailing 12 months
7 clearances under product code MRW 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 MRW, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260