meddevicedb.com FDA Device Reference

InSpace Subacromial Tissue Spacer System

DEN200039 Class II Direct
Decision Date
2021-07-12
Sponsor / Applicant
Ortho-Space , Ltd.

Technical Specification

510(k) Submission ID DEN200039
Product Code QPQ
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3630
Decision Date 2021-07-12
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

InSpace Subacromial Tissue Spacer System received FDA 510(k) clearance under submission number DEN200039, sponsored by Ortho-Space , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-07-12.

Classification & Regulation

This clearance is catalogued under FDA product code QPQ and 21 CFR 888.3630, within the Orthopedic review panel as a Class II device.