SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM— 510(k) K953778

Clearance details

Applicant

Advanced Spine Fixation Systems, Inc.

Product code

Code MNH

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

1995-08-14

Decision date

1995-11-06

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Cypress, CA, US

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• K161151 — Spinal fixation system2016-09-21
• K162189 — ANAX 5.5 Spinal System2016-08-30

• K992012 — WILTSE SYSTEM2000-02-04
• K990845 — MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-151999-04-13
• K954770 — CENTRA-LINE GRAPPLE, VARIFIX SYSTEM1996-01-25
• K953779 — SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM1995-11-07
• K953369 — STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW1995-09-08

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 →