Theken Atoll Oct Spinal System
FDA 510(k) K083863 · Theken Spine, LLC
510(k) numberK083863
Submission
- Device name
- Theken Atoll Oct Spinal System
- Applicant
- Theken Spine, LLC
Akron, OH, US - Received
- December 29, 2008
- Decision date
- March 27, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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| K160320 | PremierMNI · Traditional | Shandong Weigao Orthopaedic Device Co., Ltd. | 04/01/2016SE |
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More from Changzhou Waston Medical Appliance Co., Ltd.
| 510(k) | Device | Decision |
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| K121482 | Instrument System for Endoscopic Spinal SurgeryHRX · Traditional | 08/28/2012SE |
| K121211 | Vu Apod Intervertebral Body Fusion DeviceOVD · Special | 06/27/2012SE |
| K120829 | Stainless Steel Spinal SystemNKB · Special | 05/30/2012SE |
| K120047 | Coral Spinal SystemNKB · Special | 02/03/2012SE |
| K111675 | Vu C*Pod Intervertebral Body Fusion DeviceODP · Special | 08/02/2011SE |
| K103228 | Paramount R Ibf DeviceMAX · Special | 01/05/2011SE |
| K102323 | Cervical Standalone Intervertebral Body Fusion DeviceOVE · Traditional | 12/16/2010SE |
| K101310 | Vu Apod Intervertebral Body Fusion DeviceOVD · Traditional | 09/02/2010SE |
| K100970 | Stainless Steel Spinal SystemNKB · Traditional | 08/12/2010SE |
| K091266 | Theken Coral Spinal SystemNKB · Special | 06/10/2009SE |
Questions and answers
When was Theken Atoll Oct Spinal System cleared by the FDA?
Theken Atoll Oct Spinal System (K083863) received a 510(k) decision of Substantially Equivalent on March 27, 2009, 88 days after the submission was received.
What is the product code of K083863?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.