Selby Instrumentation
FDA 510(k) K945064 · Advanced Spine Fixation Systems, Inc.
510(k) numberK945064
Submission
- Device name
- Selby Instrumentation
- Applicant
- Advanced Spine Fixation Systems, Inc.
Cypress, CA, US - Received
- October 14, 1994
- Decision date
- April 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|
| K992012 | Wiltse SystemKWQ · Traditional | 02/04/2000SE |
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| K954770 | Centra-Line Grapple, Varifix SystemKWP · Traditional | 01/25/1996SE |
| K953779 | Saddle with Anchor, Stainless Steel Varifix SystemMNH · Traditional | 11/07/1995SN |
| K953778 | Saddle with Anchor, Titanium Varifix SystemMNH · Traditional | 11/06/1995SN |
| K953369 | Stainless Steel Varifix System 5.0MM Diameter Anchor ScrewMNH · Traditional | 09/08/1995SN |
| K951308 | 5.8MM Diameter Anchor ScrewMNH · Traditional | 07/26/1995SN |
| K951172 | Titanium Low Profile Cross BarMNH · Traditional | 07/25/1995SE |
| K943775 | Selby InstrumentationMNH · Traditional | 04/26/1995SN |
| K942387 | Selby InstrumentationMNH · Traditional | 02/14/1995SN |
Questions and answers
When was Selby Instrumentation cleared by the FDA?
Selby Instrumentation (K945064) received a 510(k) decision of Substantially Equivalent on April 26, 1995, 194 days after the submission was received.
What is the product code of K945064?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.