Hall Cannlula System
by Hall Surgical, Division of Zimmer, Inc.
510(k) K862778
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862778 | Date8 Sep 1986 | 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- Withdrawn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 Hall Cannula System is a cannulated orthopedic device designed for surgical procedures involving bone preparation and implant placement. It features a tubular cannula intended to facilitate the creation of precise channels within bone, aiding in the alignment and insertion of orthopedic implants such as screws or prosthetics. The system is categorized under orthopedic instrumentation, specifically for use in procedures requiring controlled bone access.
This system is supplied as a reusable medical device and has been granted FDA 510(k) clearance under the traditional review pathway, classified as substantially equivalent to predicate devices. It is intended for use in sterile surgical environments and requires proper handling and sterilization procedures as per manufacturer guidelines. The device is regulated under the FDA’s orthopedic advisory committee (OR) and falls under product code HRX, with a K-number of K862778. No specific MRI safety information is provided in the available data.
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Questions
AI-generated answers, 1 Oct 2026
What is the Hall Cannula System used for in orthopedic surgery?
The Hall Cannula System is designed for creating precise channels in bone during surgical procedures, enabling accurate alignment and insertion of orthopedic implants such as screws or prosthetics. Its tubular cannula provides controlled access, reducing the risk of misalignment or damage to surrounding tissue.
Is the Hall Cannula System reusable or single-use?
This system is classified as a reusable medical device. It must be properly sterilized between uses according to manufacturer guidelines to maintain safety and performance in sterile surgical environments.
What regulatory approval does the Hall Cannula System hold?
The Hall Cannula System has received FDA 510(k) clearance under the traditional review pathway, demonstrating substantial equivalence to predicate devices. It is regulated under the FDA’s Orthopedic Advisory Committee (OR) and assigned product code HRX with K-number K862778.
How should the Hall Cannula System be stored and handled?
Since this is a reusable device, it must be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, it must undergo proper sterilization procedures as outlined by the manufacturer to ensure sterility and functionality in surgical settings.
Does the Hall Cannula System have any specific MRI safety information?
The available data does not provide explicit MRI safety information for the Hall Cannula System. Clinicians should consult manufacturer guidelines or additional documentation if MRI compatibility is a concern for postoperative imaging.