Modification to Hoffmann II Micro External Fixation System
FDA 510(k) K013772 · Howmedica Osteonics
510(k) numberK013772
Submission
- Device name
- Modification to Hoffmann II Micro External Fixation System
- Applicant
- Howmedica Osteonics
Allendale, NJ, US - Received
- November 13, 2001
- Decision date
- December 3, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Modification to Hoffmann II Micro External Fixation System cleared by the FDA?
Modification to Hoffmann II Micro External Fixation System (K013772) received a 510(k) decision of Substantially Equivalent on December 3, 2001, 20 days after the submission was received.
What is the product code of K013772?
The FDA product code is LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite, a Class II (moderate risk) device regulated under 21 CFR 888.3030.