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 Type Device Class Implantable

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Unlocking Assembly, A-O Male Seaspine
TECOMET INC.
UT101001
In Commercial Distribution

  • 00818069014520 ()


  • Surgical screwdriver, reusable
Unlocking Assembly, A-O Male Seaspine
TECOMET INC.
UT101001
In Commercial Distribution

  • 00818069014155 ()


  • Surgical screwdriver, reusable
4-Sided Cylindrical Handle, Fixed, SeaSpine Logo
SEASPINE ORTHOPEDICS CORPORATION
SH2-100001
In Commercial Distribution

  • 10889981246174 ()
SH2-100001

  • Surgical instrument handle, non-torque-limiting
Driver Assy, Unlock Tool for Seaspine
Shukla Medical
MMI1223
In Commercial Distribution

  • B756MMI12230 ()


  • Surgical screwdriver, reusable
Imager Adaptor for SeaSpine® Lattus Retractor, 5-pk Carton
VISEON, INC.
LTS-S
In Commercial Distribution

  • 00850007069582 ()
  • 00850007069612 ()


  • General-purpose surgical microscope
PEDICLE SUBTRACTION OSTEOTOMY SET
Avalign Technologies, Inc.
00-5489-0000-00
In Commercial Distribution

  • 00190776149628 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
STRAIGHT OSTEOTOME, 25mm
Avalign Technologies, Inc.
00-5489-1225-99
In Commercial Distribution

  • 00190776149604 ()


  • Orthopaedic osteotome
STRAIGHT OSTEOTOME, 13mm
Avalign Technologies, Inc.
00-5489-1213-99
In Commercial Distribution

  • 00190776149598 ()


  • Orthopaedic osteotome
STRAIGHT OSTEOTOME, 10mm
Avalign Technologies, Inc.
00-5489-1210-99
In Commercial Distribution

  • 00190776149581 ()


  • Orthopaedic osteotome
STRAIGHT OSTEOTOME, 6mm
Avalign Technologies, Inc.
00-5489-1206-99
In Commercial Distribution

  • 00190776149574 ()


  • Orthopaedic osteotome
8mm x 6mm VERTEBRAL BODY OSTEOTOME
Avalign Technologies, Inc.
00-5489-1186-99
In Commercial Distribution

  • 00190776149567 ()


  • Orthopaedic osteotome
6mm x 8mm VERTEBRAL BODY OSTEOTOME
Avalign Technologies, Inc.
00-5489-1168-99
In Commercial Distribution

  • 00190776149550 ()


  • Orthopaedic osteotome
POSTERIOR VERTEBRAL BODY PUNCH, 25mm WIDE
Avalign Technologies, Inc.
00-5489-0426-99
In Commercial Distribution

  • 00190776149543 ()


  • Orthopaedic osteotome
POSTERIOR VERTEBRAL BODY PUNCH, 25mm
Avalign Technologies, Inc.
00-5489-0425-99
In Commercial Distribution

  • 00190776149536 ()


  • Orthopaedic osteotome
POSTERIOR VERTEBRAL BODY PUNCH, 20mm WIDE
Avalign Technologies, Inc.
00-5489-0421-99
In Commercial Distribution

  • 00190776149529 ()


  • Orthopaedic osteotome
POSTERIOR VERTEBRAL BODY PUNCH, 20mm
Avalign Technologies, Inc.
00-5489-0420-99
In Commercial Distribution

  • 00190776149512 ()


  • Orthopaedic osteotome
ANGULAR TEMPLATE, 35degrees
Avalign Technologies, Inc.
00-5489-0335-99
In Commercial Distribution

  • 00190776149505 ()


  • Surgical implant template, reusable
ANGULAR TEMPLATE, 30degrees
Avalign Technologies, Inc.
00-5489-0330-99
In Commercial Distribution

  • 00190776149499 ()


  • Surgical implant template, reusable
ANGULAR TEMPLATE, 25degrees
Avalign Technologies, Inc.
00-5489-0325-99
In Commercial Distribution

  • 00190776149482 ()


  • Surgical implant template, reusable
BAYONET NERVE ROOT RETRACTOR, 14mm
Avalign Technologies, Inc.
00-5489-0914-99
In Commercial Distribution

  • 00190776149475 ()


  • Nerve/vessel retractor
BAYONET NERVE ROOT RETRACTOR, 12mm
Avalign Technologies, Inc.
00-5489-0912-99
In Commercial Distribution

  • 00190776149468 ()


  • Nerve/vessel retractor
BAYONET NERVE ROOT RETRACTOR, 10mm
Avalign Technologies, Inc.
00-5489-0910-99
In Commercial Distribution

  • 00190776149451 ()


  • Nerve/vessel retractor
ADJUSTABLE VERTEBRAL BODY RETRACTOR, 30mm
Avalign Technologies, Inc.
00-5489-0830-99
In Commercial Distribution

  • 00190776149444 ()


  • Self-retaining surgical retractor, reusable
ADJUSTABLE VERTEBRAL BODY RETRACTOR, 20mm
Avalign Technologies, Inc.
00-5489-0820-99
In Commercial Distribution

  • 00190776149437 ()


  • Self-retaining surgical retractor, reusable
ADJUSTABLE VERTEBRAL BODY RETRACTOR, 15mm
Avalign Technologies, Inc.
00-5489-0815-99
In Commercial Distribution

  • 00190776149420 ()


  • Self-retaining surgical retractor, reusable
PEDICLE SUBTRACTION OSTEOTOMY SET CASE
Avalign Technologies, Inc.
5287-100-001
In Commercial Distribution

  • 00190776149413 ()


  • Instrument tray, reusable
No Description
Provision
86-0712
In Commercial Distribution

  • B504OM8607120 ()


  • Drilling power tool attachment, basic
Expandable IBD Implants
SEASPINE ORTHOPEDICS CORPORATION
EXPIMP
In Commercial Distribution

  • 10889981123420 ()
EXPIMP

  • Instrument tray, reusable
Inserter
SEASPINE ORTHOPEDICS CORPORATION
98-2005
In Commercial Distribution

  • 10889981120764 ()
98-2005

  • Orthopaedic implant inserter/extractor, reusable
Long Bullet Distractor, 8mm
SEASPINE ORTHOPEDICS CORPORATION
93-3616
In Commercial Distribution

  • 10889981089351 ()

  • 8mm
93-3616

  • Orthopaedic surgical distractor, internal
Long Bullet Distractor, 7mm
SEASPINE ORTHOPEDICS CORPORATION
93-3615
In Commercial Distribution

  • 10889981089344 ()

  • 7mm
93-3615

  • Orthopaedic surgical distractor, internal
Paddle Scraper, Convex, 18mm
SEASPINE ORTHOPEDICS CORPORATION
93-3611
In Commercial Distribution

  • 10889981089337 ()

  • 18mm
93-3611

  • Bone file
Paddle Scraper, Convex, 17mm
SEASPINE ORTHOPEDICS CORPORATION
93-3610
In Commercial Distribution

  • 10889981089320 ()

  • 17mm
93-3610

  • Bone file
Paddle Scraper, Convex, 16mm
SEASPINE ORTHOPEDICS CORPORATION
93-3609
In Commercial Distribution

  • 10889981089313 ()

  • 16mm
93-3609

  • Bone file
Paddle Scraper, Convex, 15mm
SEASPINE ORTHOPEDICS CORPORATION
93-3608
In Commercial Distribution

  • 10889981089306 ()

  • 15mm
93-3608

  • Bone file
Paddle Scraper, Convex, 14mm
SEASPINE ORTHOPEDICS CORPORATION
93-3607
In Commercial Distribution

  • 10889981089290 ()

  • 14mm
93-3607

  • Bone file
Paddle Scraper, Convex, 13mm
SEASPINE ORTHOPEDICS CORPORATION
93-3606
In Commercial Distribution

  • 10889981089283 ()

  • 13mm
93-3606

  • Bone file
Paddle Scraper, Convex, 12mm
SEASPINE ORTHOPEDICS CORPORATION
93-3605
In Commercial Distribution

  • 10889981089276 ()

  • 12mm
93-3605

  • Bone file
Paddle Scraper, Convex, 11mm
SEASPINE ORTHOPEDICS CORPORATION
93-3604
In Commercial Distribution

  • 10889981089269 ()

  • 11mm
93-3604

  • Bone file
Paddle Scraper, Convex, 10mm
SEASPINE ORTHOPEDICS CORPORATION
93-3603
In Commercial Distribution

  • 10889981089252 ()

  • 10mm
93-3603

  • Bone file
Paddle Scraper, Convex, 9mm
SEASPINE ORTHOPEDICS CORPORATION
93-3602
In Commercial Distribution

  • 10889981089245 ()

  • 9mm
93-3602

  • Bone file
Paddle Scraper, Convex, 8mm
SEASPINE ORTHOPEDICS CORPORATION
93-3601
In Commercial Distribution

  • 10889981089238 ()

  • 8mm
93-3601

  • Bone file
Paddle Scraper, Convex, 7mm
SEASPINE ORTHOPEDICS CORPORATION
93-3600
In Commercial Distribution

  • 10889981089221 ()

  • 7mm
93-3600

  • Bone file
Ventura Implant/Trial Caddy, 11mm x 32mm
SEASPINE ORTHOPEDICS CORPORATION
93-3522
In Commercial Distribution

  • 10889981089214 ()

  • 11mm x 32mm
93-3522

  • Instrument tray, reusable
Ventura Implant/Trial Caddy, 11mm x 32mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
93-3521
In Commercial Distribution

  • 10889981089207 ()

  • 11mm x 32mm
93-3521

  • Instrument tray, reusable
Ventura Implant/Trial Caddy, 9mm x 32mm
SEASPINE ORTHOPEDICS CORPORATION
93-3520
In Commercial Distribution

  • 10889981089191 ()

  • 9mm x 32mm
93-3520

  • Instrument tray, reusable
Ventura Implant/Trial Caddy, 9mm x 32mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
93-3519
In Commercial Distribution

  • 10889981089184 ()

  • 9mm x 32mm
93-3519

  • Instrument tray, reusable
Ventura Bullet Distractor Instrument Tray
SEASPINE ORTHOPEDICS CORPORATION
93-3518
In Commercial Distribution

  • 10889981089177 ()
93-3518

  • Instrument tray, reusable
Ventura Box Cutter and Instrument Tray
SEASPINE ORTHOPEDICS CORPORATION
93-3517
In Commercial Distribution

  • 10889981089160 ()
93-3517

  • Instrument tray, reusable
Pacifica/Ventura Hybrid IMP and Instrument Tray
SEASPINE ORTHOPEDICS CORPORATION
93-3516
In Commercial Distribution

  • 10889981089153 ()
93-3516

  • Instrument tray, reusable
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