SCS Closed Screw
FDA 510(k) K003733 · Ortho Tec, LLC
510(k) numberK003733
Submission
- Device name
- SCS Closed Screw
- Applicant
- Ortho Tec, LLC
Beverly Hills, CA, US - Received
- December 4, 2000
- Decision date
- May 29, 2001
- 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
Other 510(k)s with product code MNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | Reliance Medical Systems, LLC | 12/02/2016SE |
| 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 |
|---|---|---|
| K040514 | Eovia Calcium Phosphate CeramicMQV · Traditional | 05/03/2004SE |
| K040346 | Modification to Oria Top Clip SystemMNI · Special | 03/12/2004SE |
| K030958 | Oria Spinal System, Domino and Tube ConnectorsMNI · Traditional | 11/20/2003SE |
| K031471 | Oria Spinal Clip System, Lateral Intermediate Connector, Model AL01KWP · Traditional | 10/10/2003SE |
| K023884 | Modification Oria Spinal SystemKWP · Traditional | 08/20/2003SE |
| K023378 | Oria ClarisMNH · Traditional | 06/27/2003SE |
| K031452 | Oria Spinal Clip System, Sacral Connector, Models CA03 and AO03KWP · Special | 06/18/2003SE |
| K030500 | Oria ZenithKWQ · Special | 03/20/2003SE |
| K023377 | Oria Cervical PlatesKWQ · Traditional | 03/04/2003SE |
| K030253 | Oria Spinal Clip System, Lengthened Lateral Connector, Model AL06KWP · Special | 02/21/2003SE |
Questions and answers
When was SCS Closed Screw cleared by the FDA?
SCS Closed Screw (K003733) received a 510(k) decision of Substantially Equivalent on May 29, 2001, 176 days after the submission was received.
What is the product code of K003733?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.