Coflex-F
FDA 510(k) K112595 · Paradigm Spine, LLC
510(k) numberK112595
Submission
- Device name
- Coflex-F
- Applicant
- Paradigm Spine, LLC
New York, NY, US - Received
- September 7, 2011
- Decision date
- February 13, 2012
- 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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| K120491 | DSS Stabilization System-RigidMNH · Traditional | 05/09/2012SESU |
| K113625 | DSS Stabilization SystemNKB · Special | 01/10/2012SESU |
| K093438 | Paradigm Interspinous Fusion PlateKWP · Traditional | 10/06/2010SE |
| K101083 | DSS Stabilization SystemNQP · Special | 07/02/2010SESU |
| K091944 | Modification to: DSS Stabilization SystemNQP · Special | 08/03/2009SE |
| K090099 | DSS Stabilization SystemNKB · Traditional | 06/19/2009SESU |
Questions and answers
When was Coflex-F cleared by the FDA?
Coflex-F (K112595) received a 510(k) decision of Substantially Equivalent on February 13, 2012, 159 days after the submission was received.
What is the product code of K112595?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.