Streamline OCT Occipito-Cervico-Thoracic System
FDA 510(k) K150254 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
510(k) numberK150254
Submission
- Device name
- Streamline OCT Occipito-Cervico-Thoracic System
- Applicant
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Marquette, MI, US - Received
- February 3, 2015
- Decision date
- April 28, 2015
- 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 |
| 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 |
| K140734 | Nextgen Altius Oct SystemKWP · Traditional | Ebi, LLC | 12/15/2014SE |
More from Ebi, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K201497 | EVOS Cabling SystemJDQ · Traditional | 10/28/2020SE |
| K200513 | DAC Dynamic Active Compression PlateHRS · Traditional | 07/22/2020SE |
| K200095 | Streamline Navigated InstrumentsOLO · Traditional | 06/26/2020SE |
| K193468 | Tritium Sternal Cable Plate SystemJDQ · Traditional | 03/12/2020SE |
| K192800 | Streamline TL Spinal Fixation SystemNKB · Traditional | 01/14/2020SE |
| K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyMAX · Traditional | 12/20/2019SE |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs:…MAX · Traditional | 07/05/2019SE |
| K183060 | CervAlign Anterior Cervical Plate SystemKWQ · Traditional | 01/17/2019SE |
| K172139 | Streamline OCT Occipito-Cervico-Thoracic SystemNKG · Traditional | 08/18/2017SE |
| K170830 | Unison-C Anterior Cervical Fixation SystemOVE · Traditional | 06/28/2017SE |
Questions and answers
When was Streamline OCT Occipito-Cervico-Thoracic System cleared by the FDA?
Streamline OCT Occipito-Cervico-Thoracic System (K150254) received a 510(k) decision of Substantially Equivalent on April 28, 2015, 84 days after the submission was received.
What is the product code of K150254?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.