Republic Spine Dark Star Spinal System
FDA 510(k) K150283 · Republic Spine, LLC
510(k) numberK150283
Submission
- Device name
- Republic Spine Dark Star Spinal System
- Applicant
- Republic Spine, LLC
Pompano Beach, FL, US - Received
- February 5, 2015
- Decision date
- April 29, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
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| K162801 | CastleLoc Spinal Fixation SystemMNH · Special | L&K BIOMED Co., Ltd. | 11/03/2016SE |
| K162143 | FixxSure® X-LinkMNH · Traditional | Innovasis, Inc. | 09/23/2016SE |
| K161151 | Spinal fixation systemMNH · Traditional | Canwell Medical Co., Ltd. | 09/21/2016SE |
| K162189 | ANAX 5.5 Spinal SystemMNH · Special | U&I Corporation | 08/30/2016SE |
| K151362 | HC Spinal SystemMNH · Traditional | Hung Chun Bio-S Co., Ltd. | 05/05/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | Zavation, LLC | 04/21/2016SE |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 03/02/2016SE |
| K143013 | Spinal Inner Fixation SystemMNH · Traditional | Changzhou Dingjian Medical Appliance Co., Ltd. | 12/11/2015SE |
| K151695 | Romeo posterior osteosynthesis systemMNH · Traditional | Spineart | 09/10/2015SE |
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Questions and answers
When was Republic Spine Dark Star Spinal System cleared by the FDA?
Republic Spine Dark Star Spinal System (K150283) received a 510(k) decision of Substantially Equivalent on April 29, 2015, 83 days after the submission was received.
What is the product code of K150283?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.