Stainless Steel Varifix System 5.0MM Diameter Anchor Screw
FDA 510(k) K953369 · Advanced Spine Fixation Systems, Inc.
510(k) numberK953369
Submission
- Device name
- Stainless Steel Varifix System 5.0MM Diameter Anchor Screw
- Applicant
- Advanced Spine Fixation Systems, Inc.
Cypress, CA, US - Received
- July 18, 1995
- Decision date
- September 8, 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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|---|---|---|---|
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| K162801 | CastleLoc Spinal Fixation SystemMNH · Special | L&K BIOMED Co., Ltd. | 11/03/2016SE |
| K162143 | FixxSure® X-LinkMNH · Traditional | Innovasis, Inc. | 09/23/2016SE |
| K161151 | Spinal fixation systemMNH · Traditional | Canwell Medical Co., Ltd. | 09/21/2016SE |
| K162189 | ANAX 5.5 Spinal SystemMNH · Special | U&I Corporation | 08/30/2016SE |
| K151362 | HC Spinal SystemMNH · Traditional | Hung Chun Bio-S Co., Ltd. | 05/05/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | Zavation, LLC | 04/21/2016SE |
| 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 |
| K953778 | Saddle with Anchor, Titanium Varifix SystemMNH · Traditional | 11/06/1995SN |
| 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 Stainless Steel Varifix System 5.0MM Diameter Anchor Screw cleared by the FDA?
Stainless Steel Varifix System 5.0MM Diameter Anchor Screw (K953369) received a 510(k) decision of Substantially Equivalent for Some Indications on September 8, 1995, 52 days after the submission was received.
What is the product code of K953369?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.