PROPOSED OPTIMUS— 510(k) K132596

Name: FDA 510(k) clearance K132596
Creator: U.S. Food and Drug Administration
Published: 2014-04-11

Substantially Equivalent

Custom Spine, Inc.

FDA 510(k) clearance K132596 for PROPOSED OPTIMUS, Substantially Equivalent on 2014-04-11. Applicant: Custom Spine, Inc.. Device class: 2.

Clearance details

Applicant: Custom Spine, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2013-08-19
Decision date: 2014-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Custom Spine, Inc.

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K143143 — PATHWAY ELIF2015-07-22
K120597 — KOMPREDA2013-05-03
K111726 — PATHWAY AVID2012-02-06
K111099 — ISSYS LP SPINAL FIXATION SYSTEM2011-05-05
K092904 — PATHWAY IVB/VBR2009-12-22

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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 K132596

K-number listed on FDA's recall record

Z-0891-2017 — Optimus Fixed AwlClass II·Terminated·Amendia, Inc·20161122

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132596.

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