Uni-Thread Spinal System
FDA 510(k) K042640 · Spine Vision, Inc.
510(k) numberK042640
Submission
- Device name
- Uni-Thread Spinal System
- Applicant
- Spine Vision, Inc.
Atlanta, GA, US - Received
- September 27, 2004
- Decision date
- November 23, 2004
- 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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| 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 |
|---|---|---|
| K052406 | Uni-Thread Spinal SystemMNI · Traditional | 11/07/2005SE |
| K030526 | Pediguard Nerve Detector SystemGWF · Traditional | 12/29/2004SE |
| K042930 | Spacevision Cage SystemMQP · Traditional | 12/28/2004SE |
| K033508 | Plus Pivot Link Universal SystemMNI · Traditional | 01/27/2004SE |
| K032398 | Plus Pivot Link Universal SystemMNI · Traditional | 10/31/2003SE |
| K022271 | Plus Pivot Link Universal SystemMNI · Traditional | 09/23/2002SE |
| K021510 | Uni-T Uni-Thread Spinal SystemMNI · Traditional | 08/01/2002SE |
| K021507 | Plus Pivot Link Universal SystemKWP · Traditional | 08/01/2002SE |
| K013312 | P.L.U.S. System (Pivot Link Universal System)KWP · Traditional | 02/13/2002SE |
| K013301 | Uni-T Spinal SystemMNI · Traditional | 02/13/2002SE |
Questions and answers
When was Uni-Thread Spinal System cleared by the FDA?
Uni-Thread Spinal System (K042640) received a 510(k) decision of Substantially Equivalent on November 23, 2004, 57 days after the submission was received.
What is the product code of K042640?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.