OCTANE-C INTERBODY FUSION DEVICE SYSTEM— 510(k) K103655

Clearance details

Applicant

Exactech, Inc.

Product code

Code ODP

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2010-12-15

Decision date

2011-06-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gainesville, FL, US

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Injury

310

Total

310

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-2120-2012 — Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).Class II·Terminated·Exactech, Inc.·20120615

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103655.