Streamline TL Spinal System
by Pioneer Surgical Technology Inc. 3 variants
510(k) K110692
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110692 | Date12 May 2011 | StatusActive |
Official records
- FDA 510(k) database K110692
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NKB
- FDA applicant
- Pioneer Surgical Technology, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Streamline TL Spinal System is a spinal fixation device that creates a rigid construct in the thoracolumbar spine using pedicle screws, set screws, rods, and Streamline TL Crosslinks. It offers a broad range of implants and instruments to allow for tailored treatment to specific patients.
The system is supplied as part of a comprehensive set of implants and instruments for creating spinal fixation constructs. It is regulated with FDA 510(k) clearance under product code NKB and was reviewed by the Orthopedic advisory committee. The device is intended for use in the thoracolumbar spine to create rigid fixation constructs.