Mini Cannulated Headed and Headless Screw Set
FDA 510(k) K120493 · Instratek, Inc.
510(k) numberK120493
Submission
- Device name
- Mini Cannulated Headed and Headless Screw Set
- Applicant
- Instratek, Inc.
Houston, TX, US - Received
- February 17, 2012
- Decision date
- May 17, 2012
- 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 |
|---|---|---|
| K133523 | Stapix Superelastic Implant Bone StaplesJDR · Traditional | 02/06/2014SE |
| K131620 | Jones-Fx Fracture SystemHWC · Traditional | 07/25/2013SE |
| K111032 | CMC Cable FixHTN · Traditional | 08/31/2011SE |
| K091763 | Michelangelo Bunion System - Mabs, Model: MA6000HTN · Special | 08/14/2009SE |
| K082384 | Hav-Lok Bunion Correction SystemHTN · Traditional | 12/08/2008SE |
| K080280 | Sub-Talar Lok, Model 7-11 MMHWC · Traditional | 03/14/2008SE |
| K940230 | Endoscopic Mortons Neuroma InstrumentsHRX · Traditional | 12/12/1994SE |
| K925083 | Endotrak SystemHRX · Traditional | 04/27/1993SE |
| K922391 | Endoscopic Carpal Tunnel InstrumentsHRX · Traditional | 08/18/1992SE |
Questions and answers
When was Mini Cannulated Headed and Headless Screw Set cleared by the FDA?
Mini Cannulated Headed and Headless Screw Set (K120493) received a 510(k) decision of Substantially Equivalent on May 17, 2012, 90 days after the submission was received.
What is the product code of K120493?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.