Romeo posterior osteosynthesis system
FDA 510(k) K151695 · Spineart
510(k) numberK151695
Submission
- Device name
- Romeo posterior osteosynthesis system
- Applicant
- Spineart
Geneva, CH - Received
- June 23, 2015
- Decision date
- September 10, 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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| K162143 | FixxSure® X-LinkMNH · Traditional | Innovasis, Inc. | 09/23/2016SE |
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| 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 |
| K151116 | CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 06/26/2015SE |
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Questions and answers
When was Romeo posterior osteosynthesis system cleared by the FDA?
Romeo posterior osteosynthesis system (K151695) received a 510(k) decision of Substantially Equivalent on September 10, 2015, 79 days after the submission was received.
What is the product code of K151695?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.