Saddle with Anchor, Titanium Varifix System
FDA 510(k) K953778 · Advanced Spine Fixation Systems, Inc.
510(k) numberK953778
Submission
- Device name
- Saddle with Anchor, Titanium Varifix System
- Applicant
- Advanced Spine Fixation Systems, Inc.
Cypress, CA, US - Received
- August 14, 1995
- Decision date
- November 6, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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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| K151362 | HC Spinal SystemMNH · Traditional | Hung Chun Bio-S Co., Ltd. | 05/05/2016SE |
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| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 03/02/2016SE |
| K143013 | Spinal Inner Fixation SystemMNH · Traditional | Changzhou Dingjian Medical Appliance Co., Ltd. | 12/11/2015SE |
| K151695 | Romeo posterior osteosynthesis systemMNH · Traditional | Spineart | 09/10/2015SE |
More from Spineart
| 510(k) | Device | Decision |
|---|---|---|
| K992012 | Wiltse SystemKWQ · Traditional | 02/04/2000SE |
| K990845 | Modification to Parts Numbered Cgt-Sl and CGT-SL-15KWP · Special | 04/13/1999SE |
| K954770 | Centra-Line Grapple, Varifix SystemKWP · Traditional | 01/25/1996SE |
| K953779 | Saddle with Anchor, Stainless Steel Varifix SystemMNH · Traditional | 11/07/1995SN |
| 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 |
| K945064 | Selby InstrumentationMNH · Traditional | 04/26/1995SE |
| K943775 | Selby InstrumentationMNH · Traditional | 04/26/1995SN |
| K942387 | Selby InstrumentationMNH · Traditional | 02/14/1995SN |
Questions and answers
When was Saddle with Anchor, Titanium Varifix System cleared by the FDA?
Saddle with Anchor, Titanium Varifix System (K953778) received a 510(k) decision of Substantially Equivalent for Some Indications on November 6, 1995, 84 days after the submission was received.
What is the product code of K953778?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.