Virage Oct Spinal Fixation System
FDA 510(k) K133556 · Zimmer Spine, Inc.
510(k) numberK133556
Submission
- Device name
- Virage Oct Spinal Fixation System
- Applicant
- Zimmer Spine, Inc.
Minneapolis, MN, US - Received
- November 19, 2013
- Decision date
- June 2, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K153631 | Zimmer Virage OCT Spinal Fixation SystemNKG · Special | 02/16/2016SE |
| K150896 | Vitality Spinal Fixation SystemNKB · Traditional | 08/31/2015SE |
| K151031 | Virage OCT Spinal Fixation SystemNKG · Traditional | 06/24/2015SE |
| K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…NKB · Traditional | 06/18/2015SE |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…KWQ · Traditional | 03/20/2015SE |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…MAX · Traditional | 02/12/2015SE |
| K142053 | Universal Clamp Spinal Fixation SystemOWI · Traditional | 10/29/2014SE |
| K141500 | Optio-C Anterior Cervical SystemKWQ · Traditional | 09/23/2014SE |
| K140611 | Trinica Anterior Lumbar Plate SystemKWQ · Traditional | 05/21/2014SE |
| K133184 | Ardis Interbody SystemMAX · Traditional | 01/30/2014SE |
Questions and answers
When was Virage Oct Spinal Fixation System cleared by the FDA?
Virage Oct Spinal Fixation System (K133556) received a 510(k) decision of Substantially Equivalent on June 2, 2014, 195 days after the submission was received.
What is the product code of K133556?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.