Axle PEEK Interspinous Fusion System
FDA 510(k) K112592 · X-Spine Systems, Inc.
510(k) numberK112592
Submission
- Device name
- Axle PEEK Interspinous Fusion System
- Applicant
- X-Spine Systems, Inc.
Miamisburg, OH, US - Received
- September 7, 2011
- Decision date
- December 5, 2011
- 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
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|---|---|---|---|
| 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 |
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| K170530 | Butrex Lumbar Buttress Plating SystemKWQ · Special | 03/22/2017SE |
| K160959 | Xsert Lumbar Expandable Interbody SystemMAX · Traditional | 11/17/2016SE |
| K162944 | Irix-C Cervical Integrated Fusion SystemOVE · Traditional | 11/07/2016SE |
| K160428 | Certex Spinal Fixation SystemNKG · Traditional | 05/05/2016SE |
Questions and answers
When was Axle PEEK Interspinous Fusion System cleared by the FDA?
Axle PEEK Interspinous Fusion System (K112592) received a 510(k) decision of Substantially Equivalent on December 5, 2011, 89 days after the submission was received.
What is the product code of K112592?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.