CLICK'X— 510(k) K992739

Clearance details

Applicant

Synthes Spine

Product code

Code MNH

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

1999-08-16

Decision date

2000-02-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Paoli, PA, US

• 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

• K122211 — SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS2012-12-17
• K120838 — SYNTHES MATRIX SYSTEM2012-07-31
• K111048 — SYNTHES SCOUT TACK FIXATION2012-06-14
• K120928 — SYNTHES MATRIX SYSTEM2012-05-18
• K120571 — SYNTHES USS CONNECTOR2012-05-14

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 →

• Z-0938-2013 — Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.Class II·Terminated·Synthes USA HQ, Inc.·20130111

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992739.