Kalix II Implant, Model 141 0XX with XX
FDA 510(k) K053093 · New Deal, S.A.
510(k) numberK053093
Submission
- Device name
- Kalix II Implant, Model 141 0XX with XX
- Applicant
- New Deal, S.A.
Planisboro, NJ, US - Received
- November 3, 2005
- Decision date
- December 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K070241 | Modification to Lapidus PlateHRS · Special | 02/08/2007SE |
| K070160 | Modification to TTC PlatesHRS · Special | 02/08/2007SE |
| K063820 | Lisfranc PlateHRS · Special | 02/08/2007SE |
| K060474 | Lisfranc PlateHRS · Traditional | 08/03/2006SE |
| K061765 | Kalix II ImplantHWC · Special | 07/18/2006SE |
| K061594 | Large Uni-Clip StapleJDR · Special | 07/03/2006SE |
| K060476 | Lapidus PlateHRS · Traditional | 05/17/2006SE |
| K060473 | TTC PlateHRS · Traditional | 05/17/2006SE |
| K052152 | B-Bop PlateHRS · Traditional | 09/13/2005SE |
| K050882 | Newdeal Ankle NailHSB · Traditional | 05/27/2005SE |
Questions and answers
When was Kalix II Implant, Model 141 0XX with XX cleared by the FDA?
Kalix II Implant, Model 141 0XX with XX (K053093) received a 510(k) decision of Substantially Equivalent on December 7, 2005, 34 days after the submission was received.
What is the product code of K053093?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.