510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K121877Substantially Equivalent

Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital Plates

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

K121877 is the FDA 510(k) clearance record for GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES, a class II device, cleared for Exactech, Inc. on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list 186 510(k) clearances for Exactech, Inc., from to . As of , FDA records show no recalls naming K121877.

Clearance record

Decision date
Received
(229 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Exactech, Inc. 2320 NW 66th Ct., Gainesville FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWP

Trailing 12 months

FDA records hold no clearances under product code KWP in the trailing twelve months.

FDA records show no clearances under product code KWP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260