SPINESMITH CYNCH SPINAL SYSTEM— 510(k) K101085

Clearance details

Applicant

Spine Smith Partners L.P.

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2010-04-19

Decision date

2010-07-01

Decision

Substantially Equivalent

Clearance type

Special

Location

Austin, TX, US

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• K122630 — IN:C2 SPINAL FIXATION SYSTEM2012-12-05
• K122168 — VISUALIF CHALLENGING ACCESS PLATE2012-10-11
• K102090 — SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM2010-09-30
• K090376 — SPINESMITH CYNCH SPINAL SYSTEM2009-04-01
• K082821 — SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM2008-10-31

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

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-0932-2013 — Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.Class II·Terminated·Spine Smith Partners LP·20120824

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101085.