Nexa Bone Screw System
FDA 510(k) K053394 · Nexa Orthopedics, Inc.
510(k) numberK053394
Submission
- Device name
- Nexa Bone Screw System
- Applicant
- Nexa Orthopedics, Inc.
San Diego, CA, US - Received
- December 6, 2005
- Decision date
- December 14, 2005
- 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 |
|---|---|---|
| K072710 | Nexfix Compression PinJDW · Traditional | 11/08/2007SE |
| K071147 | Nexa Orthopedics Total Shoulder SystemKWT · Traditional | 07/20/2007SE |
| K070688 | Nexfix Compression StapleJDR · Traditional | 05/18/2007SE |
| K060386 | Nexa Carpo Metacarpal ImplantKYI · Traditional | 05/10/2006SE |
| K060071 | Nexa Compression ScrewHWC · Traditional | 01/26/2006SE |
| K053408 | Nexa Bone Plate and Screw SystemHRS · Traditional | 12/22/2005SE |
| K051740 | Tapered Compression PinJDW · Traditional | 09/06/2005SE |
| K051406 | Osteocure Resorbable Bead KitMQV · Traditional | 08/01/2005SE |
| K033046 | Subtalar Peg ImplantMJW · Traditional | 12/23/2003SE |
| K032902 | Subtalar Arthrorisis ImplantHWC · Traditional | 12/15/2003SE |
Questions and answers
When was Nexa Bone Screw System cleared by the FDA?
Nexa Bone Screw System (K053394) received a 510(k) decision of Substantially Equivalent on December 14, 2005, 8 days after the submission was received.
What is the product code of K053394?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.