Issys Pedicle Screw System
FDA 510(k) K043522 · Custom Spine, Inc.
510(k) numberK043522
Submission
- Device name
- Issys Pedicle Screw System
- Applicant
- Custom Spine, Inc.
Conway, NH, US - Received
- December 20, 2004
- Decision date
- January 14, 2005
- 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 |
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| K111726 | Pathway AvidMAX · Traditional | 02/06/2012SE |
| K111774 | Pathway Model 07XXXXMAX · Special | 07/20/2011SE |
| K111099 | Issys LP Spinal Fixation SystemNKB · Special | 05/05/2011SE |
| K101151 | Regent Anterior Cervical PlateKWQ · Special | 05/19/2010SE |
| K092904 | Pathway Ivb/VbrODP · Traditional | 12/22/2009SE |
| K091134 | Custom Spine Regent Anterior Cervical PlateKWQ · Traditional | 08/17/2009SE |
| K090566 | Pathway AvidMAX · Traditional | 06/01/2009SE |
Questions and answers
When was Issys Pedicle Screw System cleared by the FDA?
Issys Pedicle Screw System (K043522) received a 510(k) decision of Substantially Equivalent on January 14, 2005, 25 days after the submission was received.
What is the product code of K043522?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.