Zimmer Guide Wire Devices
by Zimmer, Inc.
510(k) K191238
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191238 | Date5 Jul 2019 | 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- Withdrawn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
- HSB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3020
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
Zimmer Guide Wire Devices are surgical instruments designed to assist in fracture fixation and the stabilization of long bones during intramedullary nailing. These wires function as guides to facilitate accurate implant placement during orthopedic procedures.
The devices are provided sterile via gamma radiation for single-use clinical applications. This product has received FDA 510(k) clearance under K191238.
Other devices from Zimmer, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the primary clinical purpose of Zimmer Guide Wire Devices?
These devices are surgical instruments specifically designed to assist in fracture fixation and the stabilization of long bones. They function as guides to ensure the accurate placement of implants during orthopedic intramedullary nailing procedures.
Are these guide wires intended for reuse?
No, these devices are intended for single-use clinical applications only. They are provided sterile and should be disposed of after a single procedure to maintain patient safety and device integrity.
How are Zimmer Guide Wire Devices sterilized?
The devices are provided sterile to the clinician using gamma radiation. This sterilization method ensures the instruments are ready for immediate use in a surgical environment while meeting necessary safety standards.
What is the regulatory status of this product?
Zimmer Guide Wire Devices have received FDA 510(k) clearance under K191238. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.