Resolve Tongs Small/Medium, Resolve Tongs Medium/Large, Model JT-200D, JT-100D
by Ossur Americans (Formerly the Jerome Group)
510(k) K071173
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071173 | Date25 May 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HAX
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5960
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Resolve Tongs Small/Medium and Medium/Large (Models JT-200D and JT-100D) are classified as Tong, Skull for Traction, designed to apply longitudinal traction to the cervical spine. These devices are intended for vertebral alignment, reduction maintenance, or stabilization in neurological procedures, adhering to FDA Class II standards. Constructed for precision, they target spinal realignment under controlled traction forces, aiding in the management of spinal deformities or post-traumatic instability.
Supplied sterile for single-use, these tongs are regulated under FDA 510(k) clearance (K071173) with a Special review designation. They are intended for use in clinical settings where MRI safety is not a primary concern, as no specific MRI compatibility is noted. Available in two sizes—Small/Medium and Medium/Large—they require proper storage in a clean, dry environment to maintain sterility and functionality. Authorized under regulation number 882.5960, they are distributed exclusively for neurological applications.
Questions
AI-generated answers, 1 Oct 2026
What are the Resolve Tongs (JT-200D/JT-100D) used for in clinical practice?
The Resolve Tongs (Models JT-200D and JT-100D) are designed specifically for applying longitudinal traction to the cervical spine. They assist in vertebral alignment, maintenance of reduction, or stabilization during neurological procedures, particularly for managing spinal deformities or post-traumatic instability. The tongs provide controlled traction forces to aid in realignment under precise clinical conditions.
Are the Resolve Tongs (JT-200D/JT-100D) sterile and single-use?
Yes, the Resolve Tongs (Models JT-200D and JT-100D) are supplied sterile for single-use only. This ensures patient safety and reduces the risk of infection, as they are intended for one-time clinical application before disposal. Proper handling and storage are critical to maintaining sterility.
What sizes are available for the Resolve Tongs, and how do they differ?
The Resolve Tongs are available in two sizes: Small/Medium (Model JT-200D) and Medium/Large (Model JT-100D). The sizing accommodates different patient anatomies, allowing clinicians to select the appropriate tongs for optimal fit and traction application. The Small/Medium size is intended for smaller cervical spines, while the Medium/Large size is designed for larger or more robust patients.
How should the Resolve Tongs (JT-200D/JT-100D) be stored to preserve functionality?
The Resolve Tongs must be stored in a clean, dry environment to maintain both sterility and functionality. Exposure to moisture, dust, or contaminants can compromise their integrity or introduce microbial contamination. Follow manufacturer guidelines for packaging and storage to ensure they remain ready for single-use in clinical settings.
Are the Resolve Tongs (JT-200D/JT-100D) MRI-compatible?
The Resolve Tongs (Models JT-200D and JT-100D) are not explicitly labeled as MRI-compatible. If MRI imaging is required during or after their use, clinicians should consult the device’s specifications and consult with radiology staff to assess potential risks or compatibility issues before proceeding.