AIS Odontoid Fracture Fixation System
FDA 510(k) K142707 · Aesculap Implant System, Inc.
510(k) numberK142707
Submission
- Device name
- AIS Odontoid Fracture Fixation System
- Applicant
- Aesculap Implant System, Inc.
Center Valley, PA, US - Received
- September 22, 2014
- Decision date
- December 19, 2014
- 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 |
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| K142150 | Ais Modulift VBR SystemMQP · Traditional | 10/29/2014SE |
| K133802 | Ais Modulift VBR SystemMQP · Traditional | 04/17/2014SE |
| K122783 | Plasmafit Acetabular Cup and Vitelene InsertOQG · Traditional | 10/30/2013SE |
| K130887 | S4C Navigation InstrumentsOLO · Traditional | 08/13/2013SE |
| K123909 | Aesculap Cespace XPODP · Traditional | 04/15/2013SE |
| K130291 | S4 Spinal SystemNKB · Traditional | 04/11/2013SE |
| K122985 | Columbus Revision Knee SystemJWH · Special | 10/26/2012SE |
| K112551 | S4 Spinal SystemNKB · Special | 11/21/2011SE |
| K101281 | Vega Knee SystemJWH · Traditional | 07/30/2010SE |
| K100147 | S4 Cervical Occipital Plate Spinal SystemNKB · Special | 07/23/2010SE |
Questions and answers
When was AIS Odontoid Fracture Fixation System cleared by the FDA?
AIS Odontoid Fracture Fixation System (K142707) received a 510(k) decision of Substantially Equivalent on December 19, 2014, 88 days after the submission was received.
What is the product code of K142707?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.