Monster Screw System P24-905-0002

GUDID 00889795036308

Counter Lever/Holder, MONSTER BITE

PARAGON 28, INC.

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00889795036308
• NIH Device Record Key: 602141fe-3e2b-4682-8b85-4994b85e34c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monster Screw System
• Version Model Number: P24-905-0002
• Catalog Number: P24-905-0002
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889795036308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190586

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

[00889795036308]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2019-10-17

On-Brand Devices [Monster Screw System]

• 00889795056719: 1.2 X 150 Mm K Wire, Single Ended Trocar Tip, Threaded
• 00889795055057: JOUST Precision Beaming Compression Cap, Sm
• 00889795055040: JOUST Precision Beaming Compression Cap, Lg
• 00889795055033: JOUST Precision Beaming Reduction Guide Tube
• 00889795055026: JOUST Precision Beaming Reduction Jig
• 00889795055019: Monster Beam, Instrument Tray
• 00889795055002: Monster Beam, Instrument Case Base
• 00889795054999: Monster Beam, Case Lid
• 00889795054982: JOUST Precision Beaming Guidewire Sleeve 1.4mm
• 00889795054975: 4.6mm Drill Guide Tube
• 00889795054968: Reduction Guide, Tommy Bar
• 00889795054951: JOUST Reduction Device Caddy Lid
• 00889795054944: JOUST Reduction Device Caddy Insert
• 00889795054937: JOUST Reduction Device Caddy Base
• 00889795054920: JOUST Precision Beaming Guidewire Sleeve 2.3mm
• 00889795054913: JOUST Precision Beaming Guidewire Sleeve 1.6mm
• 00889795054906: Monster Beam, Ø7.2 Solid Part. Thrd Implant Tray
• 00889795054890: Monster Beam, Ø7.2 Solid Full Thrd Implant Tray
• 00889795054883: Monster Beam, Ø7.2 Cannulated Part. Thrd Implant Tray
• 00889795054876: Monster Beam, Ø7.2 Cannulated Full Thrd Implant Tray
• 00889795054869: Monster Beam, Implant Case Base
• 00889795054852: Monster Beam, Ø5.5 Solid Implant Tray
• 00889795054845: Monster Beam, Ø5.5 Cannulated Implant Tray
• 00889795054838: Monster Beam, Ø5.0 Solid Implant Tray
• 00889795054821: Monster Beam, Ø5.0 Cannulated Implant Tray
• 00889795054814: Beaming,Ø7.2 Instrument Caddy, Lid
• 00889795054807: Beaming, Ø7.2 Screw Caddy, Lid
• 00889795054791: Beaming, Ø7.2 Instrument Caddy, Base
• 00889795054784: Beaming, Ø7.2 Screw Caddy, Base
• 00889795054753: Caddy, Mini Monster, Instrument Lid
• 00889795054746: Beaming Instrument Case, K-Wire Tray
• 00889795054739: MINI-MONSTER Solid Caddy, Lid
• 00889795054715: Caddy, Mini Monster, 3.0mm Lag Screw, Instrument Base
• 00889795054708: Caddy, Mini Monster, 3.0mm Lag Screw, Lid
• 00889795054692: Caddy, Mini Monster, 3.0mm Lag Screw, Base
• 00889795054685: Caddy, Mini Monster, 2.5mm Lag Screw, Instrument Base
• 00889795054678: Caddy, Mini Monster, 2.5mm Lag Screw, Lid
• 00889795054661: Caddy, Mini Monster, 2.5mm Lag Screw, Base
• 00889795054654: Caddy, Mini Monster, 2.0mm Lag Screw, Instrument Base
• 00889795054647: Caddy, Mini Monster, 2.0mm Lag Screw, Lid
• 00889795054630: Mini Monster, 2.0mm Lag Screw Caddy Base
• 00889795054623: Caddy, Mini Monster, 4.0mm Lag Screw, Instrument Base
• 00889795054616: Caddy, Mini Monster, 4.0mm Lag Screw, Lid
• 00889795054609: Caddy, Mini Monster, 4.0mm Lag Screw, Base
• 00889795054593: Caddy, Mini Monster, 3.5mm Lag Screw, Instrument Base
• 00889795054586: Caddy, Mini Monster, 3.5mm Lag Screw, Lid
• 00889795054579: Caddy, Mini Monster, 3.5mm Lag Screw, Base
• 00889795054562: Long K-wire Caddy Assembly
• 00889795054555: Short K-wire Caddy Assembly
• 00889795052384: Driver, Cannulated, Hexalobe HX15