Inter-Os Bone Generator
510(k) K993869
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993869 | Date19 Jan 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQN
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.4760
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Inter-Os Bone Generator is an External Mandibular Fixator and/or Distractor, designed for distraction osteogenesis in facial bone reconstruction. It facilitates controlled separation of bone segments following an osteotomy, promoting new bone formation through gradual distraction. This device is intended for surgical implantation by dental professionals to address mandibular or maxillofacial defects.
The device is supplied as a reusable surgical instrument and is classified under FDA regulation 872.4760 as a Class II medical device. It is intended for use in sterile conditions within an operating room setting and requires proper handling and storage as per manufacturer guidelines. The Inter-Os Bone Generator holds an FDA 510(k) clearance (K993869) under the Traditional 510(k) review pathway, with a decision date of January 19, 2000. No specific MRI safety or single-use designation is noted in the regulatory data.
Other devices from Inter-Os Technologies
Questions
AI-generated answers, 1 Oct 2026
What is the Inter-Os Bone Generator used for?
The Inter-Os Bone Generator is designed specifically for distraction osteogenesis in mandibular or maxillofacial reconstruction. It facilitates controlled separation of bone segments after an osteotomy, allowing gradual distraction to promote new bone formation. This process is critical for addressing defects in the jaw or facial bones, enabling surgical reconstruction and restoration of function.
Is the Inter-Os Bone Generator reusable or single-use?
The Inter-Os Bone Generator is supplied as a reusable surgical instrument. It is intended for multiple uses under strict sterile conditions, adhering to manufacturer guidelines for proper handling and reprocessing. Reusability is a key feature, ensuring cost-effectiveness and compliance with FDA classification as a Class II device.
What regulatory pathway does the Inter-Os Bone Generator follow?
The Inter-Os Bone Generator holds an FDA 510(k) clearance (K993869) under the Traditional 510(k) review pathway, with a decision date of January 19, 2000. It is classified under FDA regulation 872.4760 as an External Mandibular Fixator and/or Distractor, categorized under the Dental medical specialty. The device is also registered with multiple FEI numbers, reflecting its compliance and regulatory tracking.
How should the Inter-Os Bone Generator be stored?
The Inter-Os Bone Generator must be stored in a clean, dry environment to maintain its integrity and sterility. Since it is a reusable device, storage should follow manufacturer guidelines for surgical instruments, including proper packaging and protection from contamination. It is intended for use in sterile operating room conditions, so adherence to sterile storage protocols is essential before and after each use.
Does the Inter-Os Bone Generator have any specific MRI safety considerations?
The regulatory data for the Inter-Os Bone Generator does not specify any particular MRI safety designation. Clinicians should consult the manufacturer’s instructions for use to determine compatibility with MRI environments, as external fixation devices may pose risks in magnetic fields. Always verify safety protocols before use in proximity to MRI equipment.