Oria Spinal Clip System, Sacral Connector, Models CA03 and AO03
FDA 510(k) K031452 · Ortho Tec, LLC
510(k) numberK031452
Submission
- Device name
- Oria Spinal Clip System, Sacral Connector, Models CA03 and AO03
- Applicant
- Ortho Tec, LLC
California, CA, US - Received
- May 7, 2003
- Decision date
- June 18, 2003
- 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 |
|---|---|---|
| K040514 | Eovia Calcium Phosphate CeramicMQV · Traditional | 05/03/2004SE |
| K040346 | Modification to Oria Top Clip SystemMNI · Special | 03/12/2004SE |
| K030958 | Oria Spinal System, Domino and Tube ConnectorsMNI · Traditional | 11/20/2003SE |
| K031471 | Oria Spinal Clip System, Lateral Intermediate Connector, Model AL01KWP · Traditional | 10/10/2003SE |
| K023884 | Modification Oria Spinal SystemKWP · Traditional | 08/20/2003SE |
| K023378 | Oria ClarisMNH · Traditional | 06/27/2003SE |
| K030500 | Oria ZenithKWQ · Special | 03/20/2003SE |
| K023377 | Oria Cervical PlatesKWQ · Traditional | 03/04/2003SE |
| K030253 | Oria Spinal Clip System, Lengthened Lateral Connector, Model AL06KWP · Special | 02/21/2003SE |
| K030252 | Oria Spinal Clip System Extended Omniaxial Connectors (CO05 & CO07)KWP · Special | 02/21/2003SE |
Questions and answers
When was Oria Spinal Clip System, Sacral Connector, Models CA03 and AO03 cleared by the FDA?
Oria Spinal Clip System, Sacral Connector, Models CA03 and AO03 (K031452) received a 510(k) decision of Substantially Equivalent on June 18, 2003, 42 days after the submission was received.
What is the product code of K031452?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.