4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N
FDA 510(k) K043351 · Triage Medical, Inc.
510(k) numberK043351
Submission
- Device name
- 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N
- Applicant
- Triage Medical, Inc.
Irvine, CA, US - Received
- December 6, 2004
- Decision date
- February 18, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRW – System, Facet Screw Spinal Device
- Device class
- Unclassified
- Implant
- Yes
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| K251714 | Ion-CMRW · Traditional | SurGenTec, LLC | 01/16/2026SE |
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| K253190 | CORUS-LX ImplantMRW · Traditional | Providence Medical Technology, Inc. | 11/20/2025SE |
| K252153 | FFX Facet Fixation SystemMRW · Traditional | Sc Medica | 10/16/2025SE |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantMRW · Special | Providence Medical Technology, Inc. | 07/10/2025SE |
| K250920 | Arthrex Spine Compression FT ScrewMRW · Traditional | Arthrex, Inc. | 05/22/2025SE |
| K242527 | The Karma® Fixation SystemMRW · Traditional | Spinal Elements, Inc. | 05/21/2025SE |
More from Spinal Elements, 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 |
| 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 |
| K012280 | Titanium Compression Anchor System Model Version 2HWC · Special | 08/17/2001SE |
Questions and answers
When was 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N cleared by the FDA?
4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N (K043351) received a 510(k) decision of Substantially Equivalent on February 18, 2005, 74 days after the submission was received.
What is the product code of K043351?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.