Device Modification of Silhouette Spindal Fixation System
FDA 510(k) K012173 · Sulzer Spine-Tech
510(k) numberK012173
Submission
- Device name
- Device Modification of Silhouette Spindal Fixation System
- Applicant
- Sulzer Spine-Tech
Minneapolis, MN, US - Received
- July 12, 2001
- Decision date
- September 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation SystemKWP · Traditional | L&K BIOMED Co., Ltd. | 07/29/2015SE |
| K150753 | OASYS SystemKWP · Traditional | Stryker Corporation | 06/09/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | Precision Spine, Inc. | 06/04/2015SE |
| K142867 | Reliance Posterior Cervical-Thoracic SystemKWP · Special | Reliance Medical Systems, LLC | 04/29/2015SE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 04/28/2015SE |
| K142253 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/23/2015SE |
| K150229 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K143249 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K142741 | OASYS SystemKWP · Traditional | Stryker Corporation | 01/15/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | K2m | 12/22/2014SE |
More from K2m
| 510(k) | Device | Decision |
|---|---|---|
| K022374 | Cadence Spinal Fixation SystemKWP · Special | 09/24/2002SE |
| K020344 | RPX Titanium Cemnt RestrictorJDK · Traditional | 05/02/2002SE |
| K020196 | Modification to Silhouette Spinal Fixation SystemMNH · Special | 02/15/2002SE |
| 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 Device Modification of Silhouette Spindal Fixation System cleared by the FDA?
Device Modification of Silhouette Spindal Fixation System (K012173) received a 510(k) decision of Substantially Equivalent on September 28, 2001, 78 days after the submission was received.
What is the product code of K012173?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.