Olsen Medical Anterior Cervical Vertebrae Plate System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K042073 FDA 510(k)
- FDA Product Code
- KWQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3060 FDA 510(k)
- Regulation Number
- 888.3060 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Olsen Medical Anterior Cervical Vertebrae Plate System is an Appliance, Fixation, Spinal Intervertebral Body device (product code KWQ) designed for anterior screw fixation of the cervical spine (C2 to C7). It provides structural support and stabilization to address degenerative disc disease, spondylolisthesis, or traumatic cervical spine injuries, including fractures. The system includes dynamic and semiconstrained plates to facilitate proper alignment and fusion of vertebrae. Its primary function is to maintain spinal integrity during the healing process while minimizing motion at the treated segments.
This device is supplied as a sterile, single-use system and is intended for use in surgical settings where spinal stabilization is required. It is classified under Regulation 888.3060 and holds an FDA 510(k) clearance (K042073) under the Traditional review pathway, determined to be Substantially Equivalent to a predicate device. The system is not MRI-safe and must be handled and stored according to manufacturer guidelines to ensure sterility and functionality. No additional regulatory markings beyond the FDA clearance are stated in the specifications.
Frequently asked questions
What is the Olsen Medical Anterior Cervical Vertebrae Plate System used for?
This system is designed for anterior screw fixation of the cervical spine (C2 to C7) to provide structural support and stabilization. It addresses conditions like degenerative disc disease, spondylolisthesis, or traumatic injuries (e.g., fractures) by maintaining spinal integrity during healing while minimizing motion at treated segments. The dynamic and semiconstrained plates ensure proper alignment and facilitate vertebral fusion.
Is the Olsen Medical Anterior Cervical Vertebrae Plate System sterile and single-use?
Yes, the system is supplied sterile and intended for single-use only. Sterility is critical for surgical settings, and reuse is not recommended to prevent contamination or compromise of functionality. Always follow manufacturer guidelines for handling and storage to preserve sterility.
What types of plates does the system include, and how do they differ?
The system includes dynamic and semiconstrained plates. Dynamic plates allow limited motion to promote physiological loading, while semiconstrained plates offer more rigidity to stabilize vertebrae precisely. This dual design accommodates varying clinical needs, from early mobility to rigid fixation during fusion.
Can this device be used with MRI imaging after surgery?
No, the Olsen Medical Anterior Cervical Vertebrae Plate System is not MRI-safe. Metallic components may interfere with MRI scans, posing risks to patients and imaging accuracy. Always verify imaging protocols with your radiology team preoperatively.
How should the system be stored to maintain sterility and functionality?
Store the system in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants. Follow the manufacturer’s instructions for expiration dates and re-sterilization warnings, as single-use devices are not intended for reprocessing.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Olsen Medical Anterior Cervical Vertebrae Plate System, K042073 - Olsen Medical Anterior Cervical Vertebrae Plate System, OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042073 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Olsen Medical
Sources (1)
- FDA 510(k) K042073 24 fields · synced Oct 6, 2026