Bone-Lok HP Washer
FDA 510(k) K040250 · Triage Medical, Inc.
510(k) numberK040250
Submission
- Device name
- Bone-Lok HP Washer
- Applicant
- Triage Medical, Inc.
Irvine, CA, US - Received
- February 2, 2004
- Decision date
- March 23, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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More from Vilex, LLC
| 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 |
| 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 Bone-Lok HP Washer cleared by the FDA?
Bone-Lok HP Washer (K040250) received a 510(k) decision of Substantially Equivalent on March 23, 2004, 50 days after the submission was received.
What is the product code of K040250?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.