Monster Screw System P20-155-070F

GUDID 00889795004864

5.5 x 70 mm Headed, Cannulated, Full Thread Screw

PARAGON 28, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00889795004864
NIH Device Record Keye7538e54-c639-4495-9ebb-7a8e5b998b04
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonster Screw System
Version Model NumberP20-155-070F
Catalog NumberP20-155-070F
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889795004864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

[00889795004864]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-19
Device Publish Date2016-09-24

On-Brand Devices [Monster Screw System]

008897950567191.2 X 150 Mm K Wire, Single Ended Trocar Tip, Threaded
00889795055057JOUST Precision Beaming Compression Cap, Sm
00889795055040JOUST Precision Beaming Compression Cap, Lg
00889795055033JOUST Precision Beaming Reduction Guide Tube
00889795055026JOUST Precision Beaming Reduction Jig
00889795055019Monster Beam, Instrument Tray
00889795055002Monster Beam, Instrument Case Base
00889795054999Monster Beam, Case Lid
00889795054982JOUST Precision Beaming Guidewire Sleeve 1.4mm
008897950549754.6mm Drill Guide Tube
00889795054968Reduction Guide, Tommy Bar
00889795054951JOUST Reduction Device Caddy Lid
00889795054944JOUST Reduction Device Caddy Insert
00889795054937JOUST Reduction Device Caddy Base
00889795054920JOUST Precision Beaming Guidewire Sleeve 2.3mm
00889795054913JOUST Precision Beaming Guidewire Sleeve 1.6mm
00889795054906Monster Beam, Ø7.2 Solid Part. Thrd Implant Tray
00889795054890Monster Beam, Ø7.2 Solid Full Thrd Implant Tray
00889795054883Monster Beam, Ø7.2 Cannulated Part. Thrd Implant Tray
00889795054876Monster Beam, Ø7.2 Cannulated Full Thrd Implant Tray
00889795054869Monster Beam, Implant Case Base
00889795054852Monster Beam, Ø5.5 Solid Implant Tray
00889795054845Monster Beam, Ø5.5 Cannulated Implant Tray
00889795054838Monster Beam, Ø5.0 Solid Implant Tray
00889795054821Monster Beam, Ø5.0 Cannulated Implant Tray
00889795054814Beaming,Ø7.2 Instrument Caddy, Lid
00889795054807Beaming, Ø7.2 Screw Caddy, Lid
00889795054791Beaming, Ø7.2 Instrument Caddy, Base
00889795054784Beaming, Ø7.2 Screw Caddy, Base
00889795054753Caddy, Mini Monster, Instrument Lid
00889795054746Beaming Instrument Case, K-Wire Tray
00889795054739MINI-MONSTER Solid Caddy, Lid
00889795054715Caddy, Mini Monster, 3.0mm Lag Screw, Instrument Base
00889795054708Caddy, Mini Monster, 3.0mm Lag Screw, Lid
00889795054692Caddy, Mini Monster, 3.0mm Lag Screw, Base
00889795054685Caddy, Mini Monster, 2.5mm Lag Screw, Instrument Base
00889795054678Caddy, Mini Monster, 2.5mm Lag Screw, Lid
00889795054661Caddy, Mini Monster, 2.5mm Lag Screw, Base
00889795054654Caddy, Mini Monster, 2.0mm Lag Screw, Instrument Base
00889795054647Caddy, Mini Monster, 2.0mm Lag Screw, Lid
00889795054630Mini Monster, 2.0mm Lag Screw Caddy Base
00889795054623Caddy, Mini Monster, 4.0mm Lag Screw, Instrument Base
00889795054616Caddy, Mini Monster, 4.0mm Lag Screw, Lid
00889795054609Caddy, Mini Monster, 4.0mm Lag Screw, Base
00889795054593Caddy, Mini Monster, 3.5mm Lag Screw, Instrument Base
00889795054586Caddy, Mini Monster, 3.5mm Lag Screw, Lid
00889795054579Caddy, Mini Monster, 3.5mm Lag Screw, Base
00889795054562Long K-wire Caddy Assembly
00889795054555Short K-wire Caddy Assembly
00889795052384Driver, Cannulated, Hexalobe HX15
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.