Arc Surgical Biotrak Screw
FDA 510(k) K061763 · Arc Surgical, LLC
510(k) numberK061763
Submission
- Device name
- Arc Surgical Biotrak Screw
- Applicant
- Arc Surgical, LLC
Hillsboro, OR, US - Received
- June 22, 2006
- Decision date
- September 19, 2006
- 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 |
|---|---|---|
| K141559 | V-Guide for VentriculostomiesHAW · Traditional | 02/27/2015SE |
| K071616 | Arc Surgical Biotrak Pin SystemHTY · Traditional | 12/19/2007SE |
| K063244 | Arc Surgical Bone Reduction ScrewHWC · Traditional | 12/27/2006SE |
| K043176 | Arc Surgical Resorbable Compression Screw SystemHWC · Traditional | 06/17/2005SE |
Questions and answers
When was Arc Surgical Biotrak Screw cleared by the FDA?
Arc Surgical Biotrak Screw (K061763) received a 510(k) decision of Substantially Equivalent on September 19, 2006, 89 days after the submission was received.
What is the product code of K061763?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.