5.8MM Diameter Anchor Screw
FDA 510(k) K951308 · Advanced Spine Fixation Systems, Inc.
510(k) numberK951308
Submission
- Device name
- 5.8MM Diameter Anchor Screw
- Applicant
- Advanced Spine Fixation Systems, Inc.
Cypress, CA, US - Received
- March 22, 1995
- Decision date
- July 26, 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 |
| K953369 | Stainless Steel Varifix System 5.0MM Diameter Anchor ScrewMNH · Traditional | 09/08/1995SN |
| 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 5.8MM Diameter Anchor Screw cleared by the FDA?
5.8MM Diameter Anchor Screw (K951308) received a 510(k) decision of Substantially Equivalent for Some Indications on July 26, 1995, 126 days after the submission was received.
What is the product code of K951308?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.