Hoffmann Light System
FDA 510(k) K073076 · Howmedica Osteonics Corp.
510(k) numberK073076
Submission
- Device name
- Hoffmann Light System
- Applicant
- Howmedica Osteonics Corp.
Mahwah, NJ, US - Received
- October 31, 2007
- Decision date
- February 15, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…JWH · Traditional | 02/14/2013SE |
| K122853 | Novel Fit and Fill StemMEH · Traditional | 02/01/2013SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | 11/01/2012SE |
| K121308 | Hip SystemsLPH · Traditional | 07/30/2012SE |
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Questions and answers
When was Hoffmann Light System cleared by the FDA?
Hoffmann Light System (K073076) received a 510(k) decision of Substantially Equivalent on February 15, 2008, 107 days after the submission was received.
What is the product code of K073076?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.