510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K110170Substantially Equivalent

Raptor Facet Fixation System

Alphatec Spine, Inc., Carlsnad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110170 is the FDA 510(k) clearance record for RAPTOR FACET FIXATION SYSTEM, cleared for Alphatec Spine, Inc. on under FDA product code MRW (System, Facet Screw Spinal Device). FDA records list 121 510(k) clearances for Alphatec Spine, Inc., from to . As of , FDA records show no recalls naming K110170.

Clearance record

Decision date
Received
(312 days to decision)
Product code
MRW System, Facet Screw Spinal Device
Device class
Unclassified
Review panel
Unknown
Applicant
Alphatec Spine, Inc. 5818 El Camino Real, Carlsnad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRW

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