FDA device listing

MUTARS® rasp for femoral stem 12mm,MUTARS® rasp for femoral stem 13mm,MUTARS® rasp for femoral stem 14mm,MUTARS® rasp…

FDA device listing 1064634867 · innotool & greminger ag

Key facts

Proprietary names MUTARS® rasp for femoral stem 12mm,MUTARS® rasp for femoral stem 13mm,MUTARS® rasp for femoral stem 14mm,MUTARS® rasp for femoral stem 15mm,MUTARS® rasp for femoral stem 16mm,MUTARS® rasp for femoral stem 17mm,MUTARS® rasp for femoral stem 18mm,MUTARS® rasp for femoral stem 19mm,MUTARS® rasp for femoral stem 20mm
Owner/operator innotool & greminger ag
Owner/operator number 10043239
Product codes LZO
Device names LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class Class II
Classification regulations (21 CFR) 888.3353
Review panels Orthopedic
Registered establishments INNOTOOL&GREMINGER AG
Establishment registrations 3010314800
FEI numbers 3010314800
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

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

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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