Titanium Compression Anchor System Model Version 2
FDA 510(k) K012280 · Triage Medical, Inc.
510(k) numberK012280
Submission
- Device name
- Titanium Compression Anchor System Model Version 2
- Applicant
- Triage Medical, Inc.
Irvine, CA, US - Received
- July 19, 2001
- Decision date
- August 17, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K062391 | Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02…MRW · Traditional | 09/14/2006SE |
| K052043 | 3.8MM CS Facet Compression DeviceMRW · Traditional | 10/17/2005SE |
| K051949 | 4.5 MM LS Facet Compression Device with Polymer Washer, Model LSPW-45-3040MRW · Special | 08/05/2005SE |
| K043351 | 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or NMRW · Traditional | 02/18/2005SE |
| K042244 | Bone-Lok MVP Cortical-Cancellous Compression DeviceHWC · Special | 09/16/2004SE |
| K040250 | Bone-Lok HP WasherHTN · Traditional | 03/23/2004SE |
| K014304 | Bone-Lok Bioabsorbable Compression Anchor, Model BMCD-35-3050SHWC · Traditional | 03/27/2002SE |
| K014243 | Bone-Lok Bioabsorbable Compression Anchor with Titanium Fixture , Model BMCD-35-3040…HWC · Traditional | 03/26/2002SE |
| K012818 | Helical Compression Anchor System, Cannulated Single HelixHWC · Traditional | 11/20/2001SE |
| K012817 | Helical Compression Anchor System, Non-CannulatedHWC · Traditional | 11/20/2001SE |
Questions and answers
When was Titanium Compression Anchor System Model Version 2 cleared by the FDA?
Titanium Compression Anchor System Model Version 2 (K012280) received a 510(k) decision of Substantially Equivalent on August 17, 2001, 29 days after the submission was received.
What is the product code of K012280?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.