510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K112097Substantially Equivalent

Gibralt Spine Systems Facet Screw 04.0,04.5

Exactech, Inc., Gainesville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112097 is the FDA 510(k) clearance record for GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5, cleared for Exactech, Inc. on under FDA product code MRW (System, Facet Screw Spinal Device). FDA records list 186 510(k) clearances for Exactech, Inc., from to . As of , FDA records show no recalls naming K112097.

Clearance record

Decision date
Received
(122 days to decision)
Product code
MRW System, Facet Screw Spinal Device
Device class
Unclassified
Review panel
Unknown
Applicant
Exactech, Inc. 2320 NW 66th Ct., Gainesville FL
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