SYNERGY 4.0 MM, 4.5 MM VLS SCREWS— 510(k) K011437

Name: FDA 510(k) clearance K011437
Creator: U.S. Food and Drug Administration
Published: 2001-06-06

Substantially Equivalent

Interpore Cross Intl.

FDA 510(k) clearance K011437 for SYNERGY 4.0 MM, 4.5 MM VLS SCREWS, Substantially Equivalent on 2001-06-06. Applicant: Interpore Cross Intl.. Device class: 2.

Clearance details

Applicant: Interpore Cross Intl.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2001-05-10
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNI

view all

K171497 — Mikron Spinal Fixation System2017-10-12
K160731 — LumFix Spinal Fixation Sytem2016-10-04
K151458 — Double Medical Universal Spine System2016-08-22
K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04

More clearances from Interpore Cross Intl.

view all

K050861 — PEEK CAS2005-05-27
K031399 — INTERGRO DBM2005-02-18
K041407 — TITANIUM MESH IMPLANT2004-12-29
K043229 — MODIFICATION TO ALTIUS OCT SYSTEM2004-12-21
K042798 — C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM2004-11-04

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.