Mountaineer Oct Spinal System
FDA 510(k) K132332 · Medos International SARL
510(k) numberK132332
Submission
- Device name
- Mountaineer Oct Spinal System
- Applicant
- Medos International SARL
Raynham, MA, US - Received
- July 26, 2013
- Decision date
- August 22, 2013
- 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 |
|---|---|---|
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyOLO · Traditional | 05/26/2026SE |
| K260240 | SYMPHONY Navigation Ready InstrumentsOLO · Traditional | 03/27/2026SE |
| K253249 | TriALTIS Spine SystemNKB · Special | 10/21/2025SE |
| K243249 | TriALTIS Spine SystemNKB · Traditional | 01/17/2025SE |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysOLO · Traditional | 09/16/2024SE |
| K242042 | TriALTIS Spine SystemNKB · Traditional | 09/09/2024SE |
| K233684 | TriALTIS Spine SystemNKB · Special | 12/12/2023SE |
| K233366 | SYMPHONY OCT SystemNKG · Special | 11/09/2023SE |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite…MBI · Traditional | 10/06/2023SE |
| K231479 | TriALTIS Spine SystemNKB · Traditional | 09/22/2023SE |
Questions and answers
When was Mountaineer Oct Spinal System cleared by the FDA?
Mountaineer Oct Spinal System (K132332) received a 510(k) decision of Substantially Equivalent on August 22, 2013, 27 days after the submission was received.
What is the product code of K132332?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.