EXACTECH GIBRALT SPINAL SYSTEM— 510(k) K110197

Clearance details

Applicant

Exactech, Inc.

Product code

Code MNI

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2011-01-24

Decision date

2011-07-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gainesville, FL, US

• K171497 — Mikron Spinal Fixation System2017-10-12
• K160731 — LumFix Spinal Fixation Sytem2016-10-04
• K151458 — Double Medical Universal Spine System2016-08-22
• K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
• K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04

• K260583 — Equinoxe® Shoulder System2026-04-14
• K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
• K243448 — Equinoxe® Shoulder System2025-08-01
• K243275 — Equinoxe® Scapula Fracture System2025-06-26
• K243839 — Alteon® HA Femoral Stems2025-03-10

Injury

641

Total

641

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1217-2014 — Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.Class II·Terminated·Exactech, Inc.·20140106

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110197.