Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

QLR · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.4520

Classification

FDA Product Code: QLR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.4520
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, placement, or removal of spinous process spacer devices for non-fusion use.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

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