C-Jaws Cervical Compressive Mini Frame
FDA 510(k) K062181 · Medicrea Technologies
510(k) numberK062181
Submission
- Device name
- C-Jaws Cervical Compressive Mini Frame
- Applicant
- Medicrea Technologies
Round Rock, TX, US - Received
- July 31, 2006
- Decision date
- January 16, 2007
- 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 |
More from K2m
| 510(k) | Device | Decision |
|---|---|---|
| K102406 | Pass Anterior Spinal SystemKWQ · Traditional | 08/23/2011SE |
| K100544 | Impix Lumbar Interbody DeviceMAX · Special | 07/22/2010SE |
| K083798 | Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMAX · Traditional | 05/19/2010SE |
| K100297 | Pass LP Spinal SystemMNI · Traditional | 03/04/2010SE |
| K083810 | Pass LP Spinal SystemMNI · Special | 07/31/2009SE |
| K083308 | Pass LP Spinal SystemMNI · Special | 12/10/2008SE |
| K082577 | Pass LP Spinal SystemMNH · Special | 10/03/2008SE |
| K082069 | Pass 2 Spinal SystemMNI · Special | 10/03/2008SE |
| K080099 | Pass Spinal SystemMNI · Special | 04/09/2008SE |
| K072226 | Impix SpacerMAX · Traditional | 12/10/2007SE |
Questions and answers
When was C-Jaws Cervical Compressive Mini Frame cleared by the FDA?
C-Jaws Cervical Compressive Mini Frame (K062181) received a 510(k) decision of Substantially Equivalent on January 16, 2007, 169 days after the submission was received.
What is the product code of K062181?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.