TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS— 510(k) K010776

Substantially Equivalent

Corin USA

FDA 510(k) clearance K010776 for TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS, Substantially Equivalent on 2001-04-06. Applicant: Corin USA. Device class: 2.

Clearance details

Applicant: Corin USA
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2001-03-14
Decision date: 2001-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNH

K162066 — Reliance Spinal Screw System2016-12-02
K162801 — CastleLoc Spinal Fixation System2016-11-03
K162143 — FixxSure® X-Link2016-09-23
K161151 — Spinal fixation system2016-09-21
K162189 — ANAX 5.5 Spinal System2016-08-30

More clearances from Corin USA

K203751 — OMNIVision system2021-04-12
K202805 — Optimized Positioning System (OPS) Insight2020-11-20
K193545 — Corin Optimized Positioning System (OPS) Femoral2020-08-04
K193042 — Optimized Positioning System (OPS) ReView2020-06-26
K192656 — Optimized Positioning System (OPS) Insight2020-05-01

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.