ATLAS SPINE VERTEBRAL BODY REPLACEMENT— 510(k) K063205

Name: FDA 510(k) clearance K063205
Creator: U.S. Food and Drug Administration
Published: 2007-02-26

Substantially Equivalent

Atlas Spine, LLC

FDA 510(k) clearance K063205 for ATLAS SPINE VERTEBRAL BODY REPLACEMENT, Substantially Equivalent on 2007-02-26. Applicant: Atlas Spine, LLC. Device class: 2.

Clearance details

Applicant: Atlas Spine, LLC
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2006-10-23
Decision date: 2007-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04

More clearances from Atlas Spine, LLC

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K091406 — ATLAS SPINE SPACER2009-09-04
K072426 — ATLAS SPINE PEDICLE SCREW SYSTEM2007-10-19

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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 →

Recalls naming K063205

K-number listed on FDA's recall record

Z-1616-2016 — Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into positionClass II·Terminated·Atlas Spine, Inc.·20130726

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063205.

Data sourced from openFDA. This site is unofficial and independent of the FDA.