REFORM PEDICLE SCREW SYSTEM— 510(k) K121172

Name: FDA 510(k) clearance K121172
Creator: U.S. Food and Drug Administration
Published: 2012-08-08

Substantially Equivalent

Spinal USA

FDA 510(k) clearance K121172 for REFORM PEDICLE SCREW SYSTEM, Substantially Equivalent on 2012-08-08. Applicant: Spinal USA. Device class: 2.

Clearance details

Applicant: Spinal USA
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2012-04-17
Decision date: 2012-08-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Pear, MS, US

Download summary PDF View on FDA.gov ↗

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K132029 — VAULT-C INTERVERTEBRAL BODY FUSION DEVICE2013-11-25
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K131343 — REFORM PEDICLE SCREW SYSTEM2013-07-24
K130279 — REFORM PEDICLE SCREW SYSTEM2013-06-20
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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.