Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer
FDA 510(k) K092825 · Spinecraft, Inc.
510(k) numberK092825
Submission
- Device name
- Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer
- Applicant
- Spinecraft, Inc.
Westchester, IL, US - Received
- September 11, 2009
- Decision date
- March 16, 2010
- 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 |
|---|---|---|
| K253260 | ORIO-3D Cage SystemODP · Traditional | 04/16/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | 03/04/2026SE |
| K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemOLO · Traditional | 07/20/2023SE |
| K223273 | ASTRA Spine SystemNKB · Traditional | 12/22/2022SE |
| K211935 | ORIO-Ti Intervertebral Body Fusion Cage SystemODP · Traditional | 09/30/2021SE |
| K211323 | ASTRA Spine SystemNKB · Special | 06/03/2021SE |
| K181350 | ASTRA-OCT Spine SystemNKG · Traditional | 07/06/2018SE |
| K143683 | APEX-DL Spine SystemNKB · Traditional | 05/22/2015SE |
| K150417 | Astra Spine SystemNKB · Traditional | 05/19/2015SE |
| K131521 | Velox Anterior Cervical Plate SystemKWQ · Traditional | 12/24/2013SE |
Questions and answers
When was Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer cleared by the FDA?
Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer (K092825) received a 510(k) decision of Substantially Equivalent on March 16, 2010, 186 days after the submission was received.
What is the product code of K092825?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.