Cas Fixation Pin 3.2 Dia X 180 Mm Str, Cas Fixaton Pin 3.2 Dia X 80 Mm Str, Cas…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100599 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is an orthopedic stereotaxic instrument, specifically a fixation pin used in surgical procedures. It is available in three sizes: 3.2 mm diameter by 180 mm length, 3.2 mm diameter by 80 mm length, and 3.2 mm diameter by 150 mm length, all with a straight configuration.
The pins are supplied sterile and are intended for single-use, disposable application in orthopedic surgery, particularly for knee target areas as part of systems such as the Orthosoft Knee 2.4 Universal System or Rosa Knee System. The device received FDA 510(k) clearance (K100599) on April 5, 2010, and is classified under product code OLO with a traditional clearance pathway.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cas Fixation Pin 3.2 Dia X 180 Mm Str, Cas Fixaton Pin 3.2 Dia X 80 Mm ..., www.accessdata.fda.gov, fda.innolitics.com, 20-8000-000-10E - Zimmer Biomet Zimmer Cas Fixation Pin, 3.2 Od X 150 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100599 | Class II | Active |
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Manufacturer
- Manufacturer
- Orthosoft Inc
- FDA Applicant
- Orthosoft, Inc.
Sources (1)
- FDA 510(k) K100599 24 fields · synced Oct 6, 2026