Herman Cannula Set
510(k) K880203
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880203 | Date14 Apr 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Herman Cannula Set is a surgical instrument designed for orthopedic procedures, specifically categorized under product code HRX in the FDA’s 21 CFR 888.1100 nomenclature. It is intended for use in orthopedic applications, facilitating precise bone access and fixation during surgical interventions. The cannula set aids in guiding screws or other orthopedic hardware into targeted bone sites with controlled accuracy.
This device is supplied as a reusable surgical instrument and is regulated under FDA 510(k) clearance (K880203), granted on April 14, 1988, following a traditional review process. It is intended for use in sterile surgical environments and is part of orthopedic fixation systems. The set includes cannulas in various sizes, though exact dimensions are not specified in the regulatory data. No MRI safety information or single-use designation is provided in the available records.