Manual Instruments Designed For Use With Total Disc Replacement Devices

QLQ · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.4515

Classification

FDA Product Code: QLQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.4515
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.

Market data

Cleared 510(k) submissions: 8
Registered establishments: 11

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown