X-spine Pedicle Screw System— 510(k) K152132

Clearance details

Applicant

X-Spine Systems, Inc.

Product code

Code MNI

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2015-07-31

Decision date

2015-09-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Miamisburg, OH, 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

• K173832 — InTice-C Porous Ti Cervical Interbody System2018-05-17
• K180153 — X-spine Cortical Bone Screw System2018-03-15
• K170119 — Calix Lumbar Spinal Implant System2017-09-29
• K171567 — IRIX-A Lumbar Integrated Fusion System2017-08-28
• K171075 — Calix-C Cervical Interbody Spacer2017-08-01

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-1773-2026 — XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.Class II·Ongoing·XTANT Medical Holdings, Inc·20260218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152132.