Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System
FDA 510(k) K121725 · Pioneer Surgical Technology, Inc.
510(k) numberK121725
Submission
- Device name
- Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System
- Applicant
- Pioneer Surgical Technology, Inc.
Marquette, MI, US - Received
- June 12, 2012
- Decision date
- November 7, 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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| K222493 | CODA Anterior Cervical Plate SystemKWQ · Traditional | 11/18/2022SE |
| K211408 | CervAlign® Anterior Cervical Plate SystemKWQ · Traditional | 06/23/2021SE |
| K192396 | Streamline MIS Spinal Fixation SystemNKB · Traditional | 11/26/2019SE |
| K140696 | Streamline TL Spinal Fixation SystemNKB · Special | 04/10/2014SE |
| K133455 | Crossfuse II Coronal Taper, Crossfuse II HyperlordoticMAX · Traditional | 03/27/2014SE |
| K133623 | C-PlusODP · Traditional | 02/10/2014SE |
| K132050 | NB3D Bone Void FillerMQV · Traditional | 02/07/2014SE |
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Questions and answers
When was Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System cleared by the FDA?
Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System (K121725) received a 510(k) decision of Substantially Equivalent on November 7, 2012, 148 days after the submission was received.
What is the product code of K121725?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.