Product code

KWA: Prosthesis, hip, semi-constrained (metal uncemented acetabular component)

FDA product code · Class III · Orthopedic

Key facts

Product code KWA
Device Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Device class Class III
Regulation number 888.3330
Review panel Orthopedic
Medical specialty Orthopedic
Submission type PMA
GMP exempt No
Implanted device Yes
Life-sustaining or life-supporting No

At a glance

  • 100–999 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 100–999 UDI devices (GUDID)
  • 1,000+ MAUDE adverse event reports
  • 100–999 Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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