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U.S. Department of Health and Human Services

Product Classification

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Device shoulder spacer for massive irreparable rotator cuff tear, resorbable, inflatable, non-fixed
Definition A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.
Physical State Non-rigid device intended to be resorbed over time.
Technical Method The implant is designed to act as a spacer, creating a physical barrier between tissues in the subacromial space. Once positioned in the tissue space, the implant is filled with sterile solution to the pre-defined volume, sealed, and released. Following implantation, it is designed to biodegrade over a certain period of time.
Target Area Shoulder (subacromial space)
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQPQ
Premarket Review Joint Arthroplasty Devices (DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3630
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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