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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Grappler PEEK Interference Screw 8 x 25mm
Paragon 28, Inc.
P41-080-2500-S
In Commercial Distribution

  • 00889795053879 ()
P41-080-2500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 8 x 20mm
Paragon 28, Inc.
P41-080-2000-S
In Commercial Distribution

  • 00889795053862 ()
P41-080-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 7 x 25mm
Paragon 28, Inc.
P41-070-2500-S
In Commercial Distribution

  • 00889795053855 ()
P41-070-2500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 7 x 20mm
Paragon 28, Inc.
P41-070-2000-S
In Commercial Distribution

  • 00889795053848 ()
P41-070-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 6 x 25mm
Paragon 28, Inc.
P41-060-2500-S
In Commercial Distribution

  • 00889795053831 ()
P41-060-2500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 6 x 20mm
Paragon 28, Inc.
P41-060-2000-S
In Commercial Distribution

  • 00889795053824 ()
P41-060-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 6 x 15mm
Paragon 28, Inc.
P41-060-1500-S
In Commercial Distribution

  • 00889795053817 ()
P41-060-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 5.5 x 25mm
Paragon 28, Inc.
P41-055-2500-S
In Commercial Distribution

  • 00889795053800 ()
P41-055-2500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 5.5 x 20mm
Paragon 28, Inc.
P41-055-2000-S
In Commercial Distribution

  • 00889795053794 ()
P41-055-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 5.5 x 15mm
Paragon 28, Inc.
P41-055-1500-S
In Commercial Distribution

  • 00889795053787 ()
P41-055-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 5 x 25mm
Paragon 28, Inc.
P41-050-2500-S
In Commercial Distribution

  • 00889795053770 ()
P41-050-2500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 5 x 20mm
Paragon 28, Inc.
P41-050-2000-S
In Commercial Distribution

  • 00889795053763 ()
P41-050-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 5 x 15mm
Paragon 28, Inc.
P41-050-1500-S
In Commercial Distribution

  • 00889795053756 ()
P41-050-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 5 x 10mm
Paragon 28, Inc.
P41-050-1000-S
In Commercial Distribution

  • 00889795053749 ()
P41-050-1000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 4.5 x 20mm
Paragon 28, Inc.
P41-045-2000-S
In Commercial Distribution

  • 00889795053732 ()
P41-045-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 4.5 x 15mm
Paragon 28, Inc.
P41-045-1500-S
In Commercial Distribution

  • 00889795053725 ()
P41-045-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 4.5 x 10 mm
Paragon 28, Inc.
P41-045-1000-S
In Commercial Distribution

  • 00889795053718 ()
P41-045-1000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 4 x 20mm
Paragon 28, Inc.
P41-040-2000-S
In Commercial Distribution

  • 00889795053701 ()
P41-040-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 4 x 15mm
Paragon 28, Inc.
P41-040-1500-S
In Commercial Distribution

  • 00889795053695 ()
P41-040-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 4 x 10mm
Paragon 28, Inc.
P41-040-1000-S
In Commercial Distribution

  • 00889795053688 ()
P41-040-1000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
K-Wire, Single Ended Trocar Tip, SMOOTH, 0.9 x 100mm
Paragon 28, Inc.
P99-192-0910
In Commercial Distribution

  • 00889795053671 ()
P99-192-0910

  • Orthopaedic bone wire
TenoTac Female Implant Depth Gauge
Paragon 28, Inc.
P42-951-0001
In Commercial Distribution

  • 00889795053640 ()
P42-951-0001

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Female Implant Driver, T15
Paragon 28, Inc.
P42-902-T151
In Commercial Distribution

  • 00889795053633 ()
P42-902-T151

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Male Implant Inserter, T15
Paragon 28, Inc.
P42-901-T154
In Commercial Distribution

  • 00889795053626 ()
P42-901-T154

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac ø2.8mm Cannulated Drill, ø6.0mm Countersink, 20mm Long
Paragon 28, Inc.
P42-917-2820
In Commercial Distribution

  • 00889795053619 ()
P42-917-2820

  • Cannulated surgical drill bit, reusable
TenoTac Female, LONG 4.5 x 2.2 x 10mm
Paragon 28, Inc.
P42-122-0100
In Commercial Distribution

  • 00889795053602 ()
P42-122-0100

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Female, MED 4.5 x 2.2 x 7.5mm
Paragon 28, Inc.
P42-122-0075
In Commercial Distribution

  • 00889795053596 ()
P42-122-0075

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Female, SHORT, 4.5 x 2.2 x 5mm
Paragon 28, Inc.
P42-122-0050
In Commercial Distribution

  • 00889795053589 ()
P42-122-0050

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Male, 6 x 2.2 x 6.5mm
Paragon 28, Inc.
P42-022-0065
In Commercial Distribution

  • 00889795053572 ()
P42-022-0065

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Caddy Lid
Paragon 28, Inc.
P42-900-LID
In Commercial Distribution

  • 00889795053565 ()
P42-900-LID

  • Device sterilization/disinfection container, reusable
TenoTac Caddy Base
Paragon 28, Inc.
P42-900-BASE
In Commercial Distribution

  • 00889795053558 ()
P42-900-BASE

  • Device sterilization/disinfection container, reusable
PROMO Cut Guide V3
Paragon 28, Inc.
P51-908-0012
In Commercial Distribution

  • 00889795053510 ()
P51-908-0012

  • Osteotomy guide, reusable
PROMO, Precision Guide, V1.5
Paragon 28, Inc.
P51-908-0010
In Commercial Distribution

  • 00889795053503 ()
P51-908-0010

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Monster, Countersink, 7.0mm, Bowl Washer
Paragon 28, Inc.
P20-910-WB70
In Commercial Distribution

  • 00889795053497 ()
P20-910-WB70

  • Surgical countersink, reusable
Half Olive Wire, Large Olive (7mm), ø1.60mm x 9cm, Threaded
Paragon 28, Inc.
P99-205-1609
In Commercial Distribution

  • 00889795053480 ()
P99-205-1609

  • Orthopaedic bone wire
Half Olive Wire, Large Olive (7mm), ø1.60mm x 8cm, Threaded
Paragon 28, Inc.
P99-205-1608
In Commercial Distribution

  • 00889795053473 ()
P99-205-1608

  • Orthopaedic bone wire
Half Olive Wire, Large Olive (7mm), ø1.60mm x 9cm, Smooth
Paragon 28, Inc.
P99-204-1609
In Commercial Distribution

  • 00889795053466 ()
P99-204-1609

  • Orthopaedic bone wire
Half Olive Wire, Large Olive (7mm), ø1.60mm x 8cm, Smooth
Paragon 28, Inc.
P99-204-1608
In Commercial Distribution

  • 00889795053459 ()
P99-204-1608

  • Orthopaedic bone wire
K-Wire, Single Ended Trocar Tip, Threaded, 2.0 x 200mm
Paragon 28, Inc.
P99-193-2020
In Commercial Distribution

  • 00889795053442 ()
P99-193-2020

  • Orthopaedic bone wire
2.0MM X 20CM K-Wire
Paragon 28, Inc.
P99-192-2020
In Commercial Distribution

  • 00889795053435 ()
P99-192-2020

  • Orthopaedic bone wire
Over Drill, 5.2 x 120mm, Solid, AO
Paragon 28, Inc.
P99-100-5212
In Commercial Distribution

  • 00889795053374 ()
P99-100-5212

  • Fluted surgical drill bit, reusable
Over Drill, 4.5 x 120mm, Solid, AO
Paragon 28, Inc.
P99-100-4512
In Commercial Distribution

  • 00889795053367 ()
P99-100-4512

  • Fluted surgical drill bit, reusable
Lateral TTC Plate, Standard, Left
Paragon 28, Inc.
P53-402-L101
In Commercial Distribution

  • 00889795053152 ()
P53-402-L101

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Lateral TT Plate, Standard, Left
Paragon 28, Inc.
P53-402-L001
In Commercial Distribution

  • 00889795053138 ()
P53-402-L001

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Tap, Double Lead, 5.2mm
Paragon 28, Inc.
P51-911-5200
In Commercial Distribution

  • 00889795053022 ()
P51-911-5200

  • Bone tap, reusable
Tap, Double Lead, 4.5mm
Paragon 28, Inc.
P51-911-4500
In Commercial Distribution

  • 00889795053015 ()
P51-911-4500

  • Bone tap, reusable
Lapidus Nail, 3-Hole, Right, 60mm
Paragon 28, Inc.
P30-R2-5560
In Commercial Distribution

  • 00889795052933 ()
P30-R2-5560

  • Arthrodesis intramedullary nail, non-distracting
Lapidus Nail, 3-Hole, Right, 58mm
Paragon 28, Inc.
P30-R2-5558
In Commercial Distribution

  • 00889795052926 ()
P30-R2-5558

  • Arthrodesis intramedullary nail, non-distracting
Lapidus Nail, 3-Hole, Right, 56mm
Paragon 28, Inc.
P30-R2-5556
In Commercial Distribution

  • 00889795052919 ()
P30-R2-5556

  • Arthrodesis intramedullary nail, non-distracting
Lapidus Nail, 3-Hole, Right, 54mm
Paragon 28, Inc.
P30-R2-5554
In Commercial Distribution

  • 00889795052902 ()
P30-R2-5554

  • Arthrodesis intramedullary nail, non-distracting
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