Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ARTICULATING RAKE W/ RATCHET
SPINAL ELEMENTS, INC.
SP-0539
In Commercial Distribution

  • 00840916148577 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGALIF DISC CUTTER INNER SHAFT
SPINAL ELEMENTS, INC.
11421-000
In Commercial Distribution

  • 00840606174787 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGA XP™ 9MM X 28MM X 11MM 11°
SPINAL ELEMENTS
72-00-092811-11
In Commercial Distribution

  • 00840916124687 ()


  • Metallic spinal interbody fusion cage
instrument Rosa 3.0 instrument Rosa 3.1 Alpha Omega microdrive holder
MEDTECH
ROSA-128E
In Commercial Distribution

  • 03760244031181 ()
ROSAS00319

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system
ALPHA OMEGA MICRODRIVE HOLDER FOR CRW ADAPTOR instrument Rosa 3.0 instrument Rosa 3.1 Alpha Omega microdrive holder for CRW supplied with M5 x 10 wing nut
MEDTECH
ROSA3-196A
Not in Commercial Distribution

  • 03760244031365 ()
ROSAS00344

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-172-720
In Commercial Distribution

  • 09348215076566 ()


  • Orthopaedic implant driver
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega HS
In Commercial Distribution

  • 07290014954922 ()
750-000070-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega HS
In Commercial Distribution

  • 07290014954915 ()
750-000020-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114064525 ()
NOW-020021-00

  • Depth electrode
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-172-700
In Commercial Distribution

  • 09348215076559 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
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