Nextgen Altius Oct System
FDA 510(k) K140734 · Ebi, LLC
510(k) numberK140734
Submission
- Device name
- Nextgen Altius Oct System
- Applicant
- Ebi, LLC
Parsippany, NJ, US - Received
- March 24, 2014
- Decision date
- December 15, 2014
- 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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| K140123 | Polaris Spinal System -Translation ScrewNKB · Traditional | 04/24/2014SE |
| K113796 | Solitaire-C Cervical Spacer SystemOVE · Traditional | 04/26/2012SE |
| K111376 | Construx External Fixation DeviceKTT · Traditional | 08/03/2011SE |
| K073116 | Ebi Internal Implant SystemDZE · Traditional | 02/28/2008SE |
Questions and answers
When was Nextgen Altius Oct System cleared by the FDA?
Nextgen Altius Oct System (K140734) received a 510(k) decision of Substantially Equivalent on December 15, 2014, 266 days after the submission was received.
What is the product code of K140734?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.