Modification to Silhouette Spinal Fixation System
FDA 510(k) K020196 · Sulzer Spine-Tech
510(k) numberK020196
Submission
- Device name
- Modification to Silhouette Spinal Fixation System
- Applicant
- Sulzer Spine-Tech
Minneapolis, MN, US - Received
- January 22, 2002
- Decision date
- February 15, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K022374 | Cadence Spinal Fixation SystemKWP · Special | 09/24/2002SE |
| K020344 | RPX Titanium Cemnt RestrictorJDK · Traditional | 05/02/2002SE |
| K012173 | Device Modification of Silhouette Spindal Fixation SystemKWP · Special | 09/28/2001SE |
| K012305 | Modification to: Trinica Anterior Cervical Plate SystemKWQ · Special | 08/22/2001SE |
| K993067 | Silhouette Spinal Fixation SystemKWP · Special | 11/16/1999SE |
| K992276 | Modification to Silhouette Spinal Fixation SystemMNI · Traditional | 10/01/1999SE |
Questions and answers
When was Modification to Silhouette Spinal Fixation System cleared by the FDA?
Modification to Silhouette Spinal Fixation System (K020196) received a 510(k) decision of Substantially Equivalent on February 15, 2002, 24 days after the submission was received.
What is the product code of K020196?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.