TiLock 1
by Genesys Orthopedics Systems LLC 1,000+ variants
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Overview
Explore the TiLock orthosis, a straight rod device for spinal fixation and stabilization.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM719G10051550 | Date31 Jul 2015 | StatusListed |
Recalls
-
- Terminated Z-2677-2014
The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- TiLock
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile
- Model / Ref / Catalog
- 1, G100-5-155
- Primary DI / UDI-DI
- M719G10051550
- 510(k) Number
- FDA Product Code
- NKB, MNI, MNH
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile
- Device Class
- Class II
- Regulation Number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Length — 155 Millimeter
Other devices from Genesys Orthopedics Systems LLC
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No