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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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Angled Single Barrel Guide
Spineup, Inc.
RO0009ASBG
In Commercial Distribution

  • B806RO0009ASBG0 ()
RO0009ASBG

  • Surgical drill guide, reusable
Single Barrel Guide
Spineup, Inc.
RO0008SBGZ
In Commercial Distribution

  • B806RO0008SBGZ0 ()
RO0008SBGZ

  • Surgical drill guide, reusable
Romero Large Introducer for Extended Heights (H is greater than or equal to 10)
Spineup, Inc.
RO0006LIEH
In Commercial Distribution

  • B806RO0006LIEH0 ()
RO0006LIEH

  • Orthopaedic inorganic implant inserter/extractor, reusable
Romero Large Introducer for Standard Heights (H is less than 10)
Spineup, Inc.
RO0005LISH
In Commercial Distribution

  • B806RO0005LISH0 ()
RO0005LISH

  • Orthopaedic inorganic implant inserter/extractor, reusable
Narrow Introducer for Extended Heights H is greater than or equal to 10
Spineup, Inc.
RO0004NIEH
In Commercial Distribution

  • B806RO0004NIEH0 ()
RO0004NIEH

  • Orthopaedic inorganic implant inserter/extractor, reusable
Narrow Introducer for Standard Heights is less than or equal to 10
Spineup, Inc.
RO0003NISH
In Commercial Distribution

  • B806RO0003NISH0 ()
RO0003NISH

  • Orthopaedic inorganic implant inserter/extractor, reusable
Romero Lateral Finishing Impactor XL
Spineup, Inc.
RO0002LFIX
In Commercial Distribution

  • B806RO0002LFIX0 ()
RO0002LFIX

  • Orthopaedic implant impactor, reusable
Romero Compaction Base
Spineup, Inc.
RO0001CBZZ
In Commercial Distribution

  • B806RO0001CBZZ0 ()
RO0001CBZZ

  • Bone graft packing block
Universal Cervical Tap
Spineup, Inc.
GN0110T1US
In Commercial Distribution

  • B806GN0110T1US0 ()
GN0110T1US

  • Bone tap, reusable
Cervical Drill Revision with Stop L22
Spineup, Inc.
GN0104D222
In Commercial Distribution

  • B806GN0104D2220 ()
GN0104D222

  • Fluted surgical drill bit, reusable
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