PASS LP SPINAL SYSTEM— 510(k) K083308

Name: FDA 510(k) clearance K083308
Creator: U.S. Food and Drug Administration
Published: 2008-12-10

Substantially Equivalent

Medicrea Technologies

FDA 510(k) clearance K083308 for PASS LP SPINAL SYSTEM, Substantially Equivalent on 2008-12-10. Applicant: Medicrea Technologies. Device class: 2.

Clearance details

Applicant: Medicrea Technologies
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2008-11-10
Decision date: 2008-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

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K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
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More clearances from Medicrea Technologies

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K102406 — PASS ANTERIOR SPINAL SYSTEM2011-08-23
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K083798 — IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF2010-05-19
K100297 — PASS LP SPINAL SYSTEM2010-03-04
K083810 — PASS LP SPINAL SYSTEM2009-07-31

Adverse events under product code MNI

product code MNI

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 →

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