Newdeal Interphalangeal Implant
FDA 510(k) K103623 · Newdeal Sas
510(k) numberK103623
Submission
- Device name
- Newdeal Interphalangeal Implant
- Applicant
- Newdeal Sas
Parc Technologique De La Prte, FR - Received
- December 10, 2010
- Decision date
- March 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HTY
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| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | Paragon 28, Inc. | 08/28/2026SE |
| K253325 | ZipToe Hammertoe Fusion SystemHTY · Traditional | Toetal Solutions | 12/29/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
| K250315 | Ronavis FX (FX-001)HTY · Traditional | AIRS, Inc. | 08/01/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 06/24/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K093914 | Newdeal Compression PlatesHRS · Traditional | 04/14/2011SE |
| K093781 | Modified: Newdeal Hallu PlatesHRS · Special | 01/22/2010SE |
| K091788 | Panta Nail (Dia. 10MM), Panta Nail XLHSB · Special | 07/29/2009SE |
| K083154 | Newdeal Hallu Lock Plate SystemHRS · Traditional | 07/10/2009SE |
| K091609 | Newdeal Compression PlateHRS · Special | 06/30/2009SE |
| K073375 | Newdeal Tibiaxys SystemHRS · Traditional | 02/21/2008SE |
| K071639 | Qwix Positioning ScrewHWC · Special | 07/09/2007SE |
| K070447 | Newdeal Compression PlateHRS · Traditional | 03/29/2007SE |
| K063831 | Basal Dorsal PlatesHRS · Traditional | 02/07/2007SE |
Questions and answers
When was Newdeal Interphalangeal Implant cleared by the FDA?
Newdeal Interphalangeal Implant (K103623) received a 510(k) decision of Substantially Equivalent on March 20, 2012, 466 days after the submission was received.
What is the product code of K103623?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.