Osteo Bone Plated
by Fred C. Bryson 510(k)
Active
510(k) K913271
Overview
The Osteo Bone Plated is a Plate, Fixation, Bone (per FDA nomenclature), designed for internal fixation of bone fractures. It provides structural support to stabilize bone segments during the healing process, ensuring proper alignment and promoting skeletal integrity.
This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified under FDA regulation 888.3030 as a Class II medical device, with a 510(k) clearance (K913271) granted under the Traditional pathway. Manufactured by Fred C. Bryson, it adheres to orthopedic fixation standards and is distributed pre-sterilized for immediate clinical use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913271 | Date17 Oct 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Fred C. Bryson
Questions
What is the Osteo Bone Plated used for in surgical settings?
The Osteo Bone Plated is designed specifically for internal fixation of bone fractures. It provides structural support to stabilize broken bone segments, helping maintain proper alignment during the healing process to ensure skeletal integrity.
Is the Osteo Bone Plated intended for reuse or is it meant for single-use only?
The Osteo Bone Plated is supplied sterile and explicitly intended for single-use in orthopedic surgical procedures. This ensures patient safety and compliance with clinical best practices.
How is the Osteo Bone Plated supplied, and is it ready for immediate use?
The device is distributed pre-sterilized, meaning it is ready for immediate clinical use right out of packaging. This eliminates the need for additional sterilization steps before surgery.
What regulatory pathway was followed for the FDA clearance of the Osteo Bone Plated?
The Osteo Bone Plated received FDA clearance under the Traditional 510(k) pathway, specifically with a clearance number K913271. It was determined to be substantially equivalent to a predicate device and falls under the orthopedic fixation category.