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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Al, SST, Nylon, Silicone
Innovasis, Inc.
BTA-119
In Commercial Distribution

  • M711BTA1190 ()


  • Instrument tray, reusable
PSO Implants
Seaspine Orthopedics Corporation
MD3-003004
In Commercial Distribution

  • 10889981273859 ()
MD3-003004

  • Instrument tray, reusable
PSO Osteotomes
Seaspine Orthopedics Corporation
MD3-003003
In Commercial Distribution

  • 10889981273668 ()
MD3-003003

  • Instrument tray, reusable
PSO Lid
Avalign Technologies, Inc.
85-6901-202-001
In Commercial Distribution

  • 00190776395339 ()


  • Instrument tray, reusable
PSO Lid
Avalign Technologies, Inc.
00-6942-152-001
In Commercial Distribution

  • 00190776403829 ()


  • Instrument tray, reusable
PSO Lid
Avalign Technologies, Inc.
00-6942-202-001
Not in Commercial Distribution

  • 00190776397456 ()


  • Instrument tray, reusable
No Description
ZIMMER DENTAL INC.
PSO
In Commercial Distribution

  • 00889024016576 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Pressure syringe with handle
PULPDENT CORPORATION
PS-O
In Commercial Distribution

  • D701PSO2 ()


  • Endodontic filling material condenser
PSO Posterior Rack
Seaspine Orthopedics Corporation
MD3-003002
In Commercial Distribution

  • 10889981273651 ()
MD3-003002

  • Instrument tray, reusable
PSO COMPRESSORS INSERT
Avalign Technologies, Inc.
89000-02-04
In Commercial Distribution

  • 00190776161194 ()


  • Instrument tray, reusable
ORTHOFIX PSO LID
Avalign Technologies, Inc.
5387-152-101
In Commercial Distribution

  • 00190776020057 ()


  • Instrument tray, reusable
PSO Auxiliary Set
Avalign Technologies, Inc.
00-5489-0002-05
In Commercial Distribution

  • 00190776397210 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
PSO Core Set
Avalign Technologies, Inc.
00-5489-0001-05
In Commercial Distribution

  • 00190776397203 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
PSO Auxiliary Set
Avalign Technologies, Inc.
85-5489-0002-99
In Commercial Distribution

  • 00190776391447 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
PSO Core Set
Avalign Technologies, Inc.
85-5489-0001-99
In Commercial Distribution

  • 00190776391232 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
ORTHOFIX PSO BASE
Avalign Technologies, Inc.
5434-150-401
In Commercial Distribution

  • 00190776381363 ()


  • Instrument tray, reusable
ELEVATOR X0315109 15MM PSO
MEDTRONIC SOFAMOR DANEK, INC.
X0315109
In Commercial Distribution

  • 00643169629127 ()


  • Bone lever/elevator, reusable
ELEVATOR X0315108 10MM PSO
MEDTRONIC SOFAMOR DANEK, INC.
X0315108
In Commercial Distribution

  • 00643169629110 ()


  • Bone lever/elevator, reusable
COMPRESSOR 5330002 PSO CONTROLLER
MEDTRONIC SOFAMOR DANEK, INC.
5330002
In Commercial Distribution

  • 00643169744547 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Mariner Deformity PSO Set
Seaspine Orthopedics Corporation
MD3-003001
In Commercial Distribution

  • 10889981273644 ()
MD3-003001

  • Instrument tray, reusable
MODIFIED INSTRUMENT PSO COMPRESSOR
DEPUY SPINE, LLC
698343240
In Commercial Distribution

  • 10705034499574 ()
698343240

  • Surgical implant handling forceps
Triangle PSO Shaver, 30°
ALPHATEC SPINE, INC.
CI-11755-30
In Commercial Distribution

  • 00840180537619 ()


  • Bone file/rasp, manual, reusable
Triangle PSO Shaver, 25°
ALPHATEC SPINE, INC.
CI-11755-25
In Commercial Distribution

  • 00840180537602 ()


  • Bone file/rasp, manual, reusable
Triangle PSO Shaver, 20°
ALPHATEC SPINE, INC.
CI-11755-20
In Commercial Distribution

  • 00840180537596 ()


  • Bone file/rasp, manual, reusable
Triangle PSO Shaver, 15°
ALPHATEC SPINE, INC.
CI-11755-15
In Commercial Distribution

  • 00840180537589 ()


  • Bone file/rasp, manual, reusable
PSO Auxiliary Set Case
Avalign Technologies, Inc.
00-5434-100-003
In Commercial Distribution

  • 00190776408268 ()


  • Instrument tray, reusable
PSO Auxiliary Set Case
Avalign Technologies, Inc.
85-6901-100-003
In Commercial Distribution

  • 00190776395322 ()


  • Instrument tray, reusable
PSO Core Set Case
Avalign Technologies, Inc.
85-6901-100-001
In Commercial Distribution

  • 00190776395315 ()


  • Instrument tray, reusable
ORTHOFIX PSO AUXILIARY BASE
Avalign Technologies, Inc.
5434-150-701
In Commercial Distribution

  • 00190776381394 ()


  • Instrument tray, reusable
PSO Auxiliary Set Case
Avalign Technologies, Inc.
00-6942-100-003
In Commercial Distribution

  • 00190776397449 ()


  • Instrument tray, reusable
PSO Core Set Case
Avalign Technologies, Inc.
00-6942-100-001
In Commercial Distribution

  • 00190776397432 ()


  • Instrument tray, reusable
ORTHOFIX PSO INSTRUMENT SET
Avalign Technologies, Inc.
42-2100
In Commercial Distribution

  • 00190776149390 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
ELEVATOR X0315111 17MM HINGED PSO
MEDTRONIC SOFAMOR DANEK, INC.
X0315111
In Commercial Distribution

  • 00643169629141 ()


  • Bone lever/elevator, reusable
ELEVATOR X0315110 13MM HINGED PSO
MEDTRONIC SOFAMOR DANEK, INC.
X0315110
In Commercial Distribution

  • 00643169629134 ()


  • Bone lever/elevator, reusable
CASE 7480504 PSO OUTER CASE
MEDTRONIC SOFAMOR DANEK, INC.
7480504
In Commercial Distribution

  • 00613994383198 ()


  • Instrument tray, reusable
PSO Auxiliary Set Sterilization Case
SPINECRAFT, LLC
6500-200
In Commercial Distribution

  • 00193082113314 ()
6500-200

  • General internal orthopaedic fixation system implantation kit
PSO Core Set Sterilization Case
SPINECRAFT, LLC
6500-100-N
In Commercial Distribution

  • 00193082113130 ()
6500-100-N

  • General internal orthopaedic fixation system implantation kit
PSO Core Set Sterilization Case
SPINECRAFT, LLC
6500-100
In Commercial Distribution

  • 00193082113123 ()
6500-100

  • General internal orthopaedic fixation system implantation kit
PSO CURETTES AND SHAVERS INSERT
Avalign Technologies, Inc.
89000-02-03
In Commercial Distribution

  • 00190776161187 ()


  • Instrument tray, reusable
PSO OSTEOTOMES AND RETRACTORS INSERT
Avalign Technologies, Inc.
89000-02-01
In Commercial Distribution

  • 00190776161163 ()


  • Instrument tray, reusable
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