Reliance Spinal Screw System
FDA 510(k) K101112 · Reliance Medical Systems
510(k) numberK101112
Submission
- Device name
- Reliance Spinal Screw System
- Applicant
- Reliance Medical Systems
Bountiful, UT, US - Received
- April 21, 2010
- Decision date
- November 4, 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 |
|---|---|---|
| K202266 | Reliance Cervical IBF SystemODP · Traditional | 03/29/2022SE |
| K210874 | Reliance Spinal Screw SystemNKB · Special | 05/13/2021SE |
| K183049 | Reliance Lumbar IBF SystemMAX · Special | 02/15/2019SE |
| K181118 | Reliance Lumbar IBF SystemOVD · Traditional | 01/09/2019SE |
| K180687 | Reliance Lumber IBF SystemMAX · Special | 05/15/2018SE |
| K173283 | Reliance Lumbar IBF SystemMAX · Special | 01/19/2018SE |
| K173102 | Reliance Cervical IBF SystemODP · Special | 12/29/2017SE |
| K172489 | Reliance Cervical IBF SystemODP · Special | 09/07/2017SE |
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | 12/02/2016SE |
| K160463 | Reliance Lumbar IBF SystemMAX · Special | 05/20/2016SE |
Questions and answers
When was Reliance Spinal Screw System cleared by the FDA?
Reliance Spinal Screw System (K101112) received a 510(k) decision of Substantially Equivalent on November 4, 2010, 197 days after the submission was received.
What is the product code of K101112?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.