Sbi Foot and Ankle Cannulated Screw System, Model 100-0061
FDA 510(k) K092754 · Small Bone Innovations, Inc.
510(k) numberK092754
Submission
- Device name
- Sbi Foot and Ankle Cannulated Screw System, Model 100-0061
- Applicant
- Small Bone Innovations, Inc.
Morrisville, PA, US - Received
- September 9, 2009
- Decision date
- January 19, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K130147 | Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)HSB · Special | 05/03/2013SE |
| K112982 | Anatomic Ankle Arthrodesis Interlocking NAIL(A3 Interlocking Nail )HSB · Traditional | 04/02/2012SE |
| K102180 | Rhead Radial Head Extended StemsJDB · Traditional | 12/20/2010SE |
| 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 Sbi Foot and Ankle Cannulated Screw System, Model 100-0061 cleared by the FDA?
Sbi Foot and Ankle Cannulated Screw System, Model 100-0061 (K092754) received a 510(k) decision of Substantially Equivalent on January 19, 2010, 132 days after the submission was received.
What is the product code of K092754?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.