ISSYS LP SPINAL FIXATION SYSTEM— 510(k) K072866

Name: FDA 510(k) clearance K072866
Creator: U.S. Food and Drug Administration
Published: 2007-12-13

Substantially Equivalent

Custom Spine, Inc.

FDA 510(k) clearance K072866 for ISSYS LP SPINAL FIXATION SYSTEM, Substantially Equivalent on 2007-12-13. Applicant: Custom Spine, Inc.. Device class: 2.

Clearance details

Applicant: Custom Spine, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2007-10-05
Decision date: 2007-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWP

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K143278 — LnK Posterior Cervical Fixation System2015-07-29
K150753 — OASYS System2015-06-09
K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System2015-06-04
K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

More clearances from Custom Spine, Inc.

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K143143 — PATHWAY ELIF2015-07-22
K132596 — PROPOSED OPTIMUS2014-04-11
K120597 — KOMPREDA2013-05-03
K111726 — PATHWAY AVID2012-02-06
K111099 — ISSYS LP SPINAL FIXATION SYSTEM2011-05-05

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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 K072866

K-number listed on FDA's recall record

Z-1819-2013 — Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.Class II·Terminated·Custom Spine, Inc.·20130328

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072866.

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