Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device prosthesis, elbow, hemi-, humeral, metal
Regulation Description Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
Definition call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKWJ
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
Regulation Number 888.3180
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
-
-