4CIS Solar and Apollon Spine Systems
FDA 510(k) K082453 · Solco Biomedical Co., Ltd.
510(k) numberK082453
Submission
- Device name
- 4CIS Solar and Apollon Spine Systems
- Applicant
- Solco Biomedical Co., Ltd.
Rockville, MD, US - Received
- August 25, 2008
- Decision date
- September 23, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code MNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | Reliance Medical Systems, LLC | 12/02/2016SE |
| 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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| K231655 | 4CIS® Chiron Spinal Fixation SystemNKB · Special | 11/26/2024SE |
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| K192044 | 4CIS Marlin PEEK ACIF CageODP · Traditional | 12/19/2019SE |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage…MAX · Traditional | 09/18/2019SE |
| K190471 | 4CIS® Chiron Spinal Fixation SystemNKB · Traditional | 07/24/2019SE |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate systemKWQ · Traditional | 01/16/2019SE |
| K162402 | 4CIS® Marlin ACIF Cage SystemODP · Traditional | 02/16/2017SE |
| K121615 | 4CIS Vane Spine SystemMNI · Special | 08/15/2012SE |
| K102458 | 4CIS Solar Spine System and 4CIS Apollon Spine SystemMNH · Special | 06/13/2011SE |
| K101818 | 4CIS Vane Spine SystemMNH · Traditional | 02/11/2011SE |
Questions and answers
When was 4CIS Solar and Apollon Spine Systems cleared by the FDA?
4CIS Solar and Apollon Spine Systems (K082453) received a 510(k) decision of Substantially Equivalent on September 23, 2008, 29 days after the submission was received.
What is the product code of K082453?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.