Anatomic Ankle Arthrodesis Interlocking NAIL(A3 Interlocking Nail )
FDA 510(k) K112982 · Small Bone Innovations, Inc.
510(k) numberK112982
Submission
- Device name
- Anatomic Ankle Arthrodesis Interlocking NAIL(A3 Interlocking Nail )
- Applicant
- Small Bone Innovations, Inc.
Morrisville, PA, US - Received
- October 6, 2011
- Decision date
- April 2, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K130147 | Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)HSB · Special | 05/03/2013SE |
| K102180 | Rhead Radial Head Extended StemsJDB · Traditional | 12/20/2010SE |
| K092754 | Sbi Foot and Ankle Cannulated Screw System, Model 100-0061HWC · Traditional | 01/19/2010SE |
| K093550 | Mini Rail External Fixator SystemKTT · Special | 01/07/2010SE |
| K073635 | Sbi SR MTP Toe ImplantKWD · Traditional | 03/19/2008SE |
| K071541 | Sbi TwistofixHWC · Traditional | 09/10/2007SE |
| K063635 | Sbi Forefoot SetHWC · Traditional | 08/29/2007SE |
| K071656 | Sbi ArtfixHWC · Traditional | 08/27/2007SE |
| K071540 | Sbi Titanium Threaded PinJDW · Traditional | 08/08/2007SE |
| K071549 | Sbi Rhead Plating SystemHRS · Traditional | 08/07/2007SE |
Questions and answers
When was Anatomic Ankle Arthrodesis Interlocking NAIL(A3 Interlocking Nail ) cleared by the FDA?
Anatomic Ankle Arthrodesis Interlocking NAIL(A3 Interlocking Nail ) (K112982) received a 510(k) decision of Substantially Equivalent on April 2, 2012, 179 days after the submission was received.
What is the product code of K112982?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.