H-H Fixation and Joining Connectors
510(k) K790849
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790849 | Date11 May 1979 | 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- Withdrawn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
- JXG
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5550
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
H-H Fixation and Joining Connectors are medical devices classified as Shunt, Central Nervous System And Components. These connectors are designed for fixation and joining purposes in neurology applications.
The device is supplied by Holter-Hausner Intl. and has FDA 510(k) clearance with product code JXG. It is a Class II device and is part of the Central Nervous System components category. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Other devices from Holter-Hausner Intl.
Questions
AI-generated answers, 24 Sep 2026
What are H-H Fixation and Joining Connectors used for?
H-H Fixation and Joining Connectors are medical devices designed for fixation and joining purposes in neurology applications. They are classified as Shunt, Central Nervous System And Components and are part of the Central Nervous System components category.
What is the regulatory status of these connectors?
The H-H Fixation and Joining Connectors have FDA 510(k) clearance with product code JXG. They are classified as a Class II device and received clearance through the traditional pathway on May 11, 1979, with K number K790849.
Are these connectors single-use or reusable?
The device data does not specify whether the H-H Fixation and Joining Connectors are single-use or reusable. No information regarding sterility, MRI safety, or storage conditions is provided in the available data.
Who manufactures these connectors and where are they supplied from?
The H-H Fixation and Joining Connectors are manufactured and supplied by Holter-Hausner Intl. The company is located at 803 N. Front St. Suite 3, Mchenry, IL 60050 in the United States.