Vertebron PSS Pedicle Screw System
FDA 510(k) K051716 · Vertebron, Inc.
510(k) numberK051716
Submission
- Device name
- Vertebron PSS Pedicle Screw System
- Applicant
- Vertebron, Inc.
Stratford, CT, US - Received
- June 27, 2005
- Decision date
- September 7, 2005
- 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 |
|---|---|---|
| K081567 | Vertebron SSP Cervical Plating SystemKWQ · Special | 07/03/2008SE |
| K081597 | Modification to Vertebron PSS Pedicle Screw SystemMNI · Special | 07/02/2008SE |
| K073502 | Vertebron VBR SystemMQP · Traditional | 03/24/2008SE |
| K071376 | Modification to Vertebron PSS Pedicle Screw SystemNKB · Special | 06/13/2007SE |
| K062110 | Vertebron SCP Cervical Plate SystemKWQ · Special | 08/16/2006SE |
| K051815 | Modification to Vertebron SCP Cervical Plate SystemKWQ · Special | 10/17/2005SE |
| K043152 | Vertebron PSS Pedicle Screw SystemMNH · Special | 02/01/2005SE |
| K043181 | Modification to Vertebron SCP Cervical Plate SystemKWQ · Special | 12/17/2004SE |
| K040003 | Vertebron SCP Cervical Plate SystemKWQ · Traditional | 03/26/2004SE |
| K033352 | Vertebron PSS Pedicle Screw SystemMNI · Traditional | 02/25/2004SE |
Questions and answers
When was Vertebron PSS Pedicle Screw System cleared by the FDA?
Vertebron PSS Pedicle Screw System (K051716) received a 510(k) decision of Substantially Equivalent on September 7, 2005, 72 days after the submission was received.
What is the product code of K051716?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.