Gorilla Plating System P53-109-L103

GUDID 00889795017932

Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Lg, TiA

PARAGON 28, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00889795017932
• NIH Device Record Key: 436f77ad-426d-4c46-9488-a1a4c79222a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gorilla Plating System
• Version Model Number: P53-109-L103
• Catalog Number: P53-109-L103
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889795017932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140397

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00889795017932]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-19
• Device Publish Date: 2016-09-24

On-Brand Devices [Gorilla Plating System]

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• 00889795018076: Gorilla, Ankle Fracture Caddy Base
• 00889795018045: Gorilla Universal Plate Caddy Lid with Strut
• 00889795018038: Gorilla Medial Column Arch Caddy Base
• 00889795017550: Universal PLate System Lid
• 00889795017543: Universal Plate System caddy Base
• 00889795017536: MTP Impant Caddy Assembly, Gorilla
• 00889795017529: Gorilla Lisfranc Implant Caddy, Base
• 00889795017512: Gorilla Lapidus Implant Caddy, Base
• 00889795017505: Calc Slide Implant Caddy Base
• 00889795017499: Gorilla Calc-Factures Implant Caddy, Base
• 00889795017475: BOW Implant caddy Lid, Gorilla
• 00889795017468: BOW Implant Caddy, Gorilla
• 00889795017451: Lid, Half Caddy
• 00889795017444: R3CON Screw Caddy Base and Lid, Gorilla
• 00889795017437: Case Lid, Full DIN
• 00889795017420: Gorilla Instrument Caddy With Lid
• 00889795017413: Plate Screw Caddy Base and Lid, Gorilla
• 00889795017406: Instrument Tray, Gorilla
• 00889795017390: Implant Caddy Tray, Gorilla
• 00889795017383: Case Base Assembly, Gorilla
• 00889795016126: CADDY, ALLOGRAFT, SUB TALAR & CALC CUBOID, HALF
• 00889795016119: CADDY, ALLOGRAFT, LAPIDUS, HALF
• 00889795016102: CADDY, ALLOGRAFT, EVANS AND COTTON, HALF
• 00889795016096: Caddy, MTP Allograft, Half
• 00889795016089: Caddy, Lid, Allograft, Half
• 00889795018083: Mini-Monster, Washer, Ø2.7mm, Flat, TiA
• 00889795001122: Gorilla Washer
• 00889795018052: Gorilla, Ankle Fx, Anatomical Fibular Plate R, 17-Hole
• 00889795018021: Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Lg, TiA
• 00889795018014: Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Md, TiA
• 00889795018007: Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Sm, TiA
• 00889795017994: Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Lg, TiA
• 00889795017987: Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Md, TiA
• 00889795017970: Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Sm, TiA
• 00889795017963: Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Lg, TiA
• 00889795017956: Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Md, TiA
• 00889795017949: Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Sm, TiA
• 00889795017932: Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Lg, TiA
• 00889795017925: Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Md, TiA
• 00889795017918: Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Sm, TiA
• 00889795017901: Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Lg, TiA
• 00889795017895: Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Md, TiA
• 00889795017888: Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Sm, TiA
• 00889795017871: Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Lg, TiA
• 00889795017864: Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Md, TiA
• 00889795017857: Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Sm, TiA
• 00889795017840: Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Lg, TiA
• 00889795017833: Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Md, TiA
• 00889795017826: Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Sm, TiA