SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION— 510(k) K132365

Clearance details

Applicant

Accel Spine

Product code

Code MNI

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2013-07-30

Decision date

2013-08-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Dallas, TX, 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

• K140219 — PICASSO II MIS SPINAL SYSTEM2014-04-14
• K131981 — CEZANNE II INTERBODY FUSION SYSTEM2013-10-09
• K132366 — SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS2013-09-03
• K121567 — ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM2012-09-26
• K121568 — DALI SPINAL FIXATION SYSTEM2012-09-21

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-1030-2019 — CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050Class II·Terminated·CTL Medical Corporation·20180705
• Z-1031-2019 — CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050Class II·Terminated·CTL Medical Corporation·20180705

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132365.