• 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, hip, constrained, metal
Regulation Description Hip joint metal constrained cemented or uncemented prosthesis.
Definition Call for PMAs 12/26/96 (61 FR 50709 (9/27/96))
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKXD
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
Regulation Number 888.3300
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
Guidance Document
Third Party Review Not Third Party Eligible
-
-