2.4 Smartnail, Models 532416, 532425, 532435, 532445
FDA 510(k) K031981 · Linvatec Biomaterials, Ltd.
510(k) numberK031981
Submission
- Device name
- 2.4 Smartnail, Models 532416, 532425, 532435, 532445
- Applicant
- Linvatec Biomaterials, Ltd.
Largo, FL, US - Received
- June 26, 2003
- Decision date
- July 25, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K052080 | Matryx Interference ScrewHWC · Special | 08/25/2005SE |
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| K042517 | Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsJEY · Special | 10/08/2004SE |
| K042295 | Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020HWC · Special | 09/16/2004SE |
| K041288 | Modification to SmartpinHTY · Special | 06/10/2004SE |
| K032894 | Osteo Acl Screw MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…HWC · Traditional | 05/07/2004SE |
| K032447 | Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedHWC · Special | 04/16/2004SE |
Questions and answers
When was 2.4 Smartnail, Models 532416, 532425, 532435, 532445 cleared by the FDA?
2.4 Smartnail, Models 532416, 532425, 532435, 532445 (K031981) received a 510(k) decision of Substantially Equivalent on July 25, 2003, 29 days after the submission was received.
What is the product code of K031981?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.