Baby Gorilla/Gorilla Plating System P53-208-0007

GUDID 00889795034489

Gorilla, Posterolateral, Fibular, 07-Hole, Alpha

PARAGON 28, INC.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID00889795034489
NIH Device Record Keye15e92c4-08a7-4c75-9b46-86ae687c4dc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBaby Gorilla/Gorilla Plating System
Version Model NumberP53-208-0007
Catalog NumberP53-208-0007
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Identifiers

Device Issuing AgencyDevice ID
GS100889795034489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889795034489]

Moist Heat or Steam Sterilization

[00889795034489]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-24
Device Publish Date2020-01-16

On-Brand Devices [Baby Gorilla/Gorilla Plating System]

00889795057594Silverback, Ankle Fusion, Lower Implant Tray
0088979505712914 x 7 Subtalar Trial
0088979505711216 x 8 Subtalar Trial
0088979505710510 x 5 Subtalar Trial
0088979505709916mm Calc-Cuboid Trial Assembly
0088979505708214mm Calc-Cuboid Trial Assembly
008897950570758mm Calc-Cuboid Trial Assembly
00889795057068Subtalar Handle
00889795057051Subtalar Coin Correction Guide
0088979505704412mm Calc-Cuboid Trial Assembly
0088979505703719 MM X 20 MM MTP DISC TRIAL HANDLE
0088979505702019 MM X 15 MM MTP DISC TRIAL HANDLE
0088979505701310 MM X 21 MM MTP DISC TRIAL HANDLE
008897950570065 MM X 21 MM MTP DISC TRIAL HANDLE
0088979505699310 MM X 18 MM MTP DISC TRIAL HANDLE
008897950569868 MM X 19 MM MTP DISC TRIAL HANDLE
008897950569795 MM X 19MM MTP DISC TRIAL HANDLE
0088979505696212 MM LAPIDUS, 12 DEGREE, TRIAL HANDLE
00889795056955Trial Handle, Lapidus, 8mm
008897950569485 MM LAPIDUS, 5 DEGREE, TRIAL HANDLE
00889795056856Foot Plate, Plantigrade Guide, Radiolucent, v 1.5
00889795056702Shannon-Style Bone Burr, 3.0mm
00889795056689Bone Graft Harvester Caddy
00889795056672K-Wire, Single Ended Trocar Tip, Threaded, 2.5 x 150mm
00889795056665Caspar Type Compression/Distraction Device
00889795056641Lobster Claw, Closed
00889795056634R3LEASE Device, 3.9 X 48mm, 17mm Notch
00889795056627R3LEASE Device, 3.9 X 48mm, 14mm Notch
00889795056450Anterior Plates, Ball Tip Wire Guide
00889795056443Gorilla R3con Drill Guide, Off Axis
00889795056436Gorilla R3con Drill Guide, Easy Guide, 2.7/3.5
00889795056429Gorilla R3con Drill Guide, 4.2 MM
00889795056412Centering Drill Guide 3.5mm, TUFFNEK
00889795056405Centering Drill Guide 4.2mm, TUFFNEK
00889795056399Gorilla R3con Drill Guide, Off Axis
00889795056382PROMO Cutting Jig
00889795056375Ø5.5mm Tissue Protector, Lateral Column Fusion
00889795056368Baby Gorilla, Implant Caddy Lid, Mini
00889795056351Baby Gorilla, Talus Fx. Plating System, Caddy Base
00889795056344Baby Gorilla Insertion Guide, Threaded
00889795056337Gorilla R3CON Drill Guide, 4.2mm
00889795056320Threaded Knob, M3 (Template Set Screw)
00889795056313BABY GORILLA Plate Caddy, Straight, L, T (Full Module)
00889795056306BABY GORILLA Plate Caddy, Oblique L, T, Y (Full Module)
00889795056290BABY GORILLA Instrument Caddy (Full Module)
00889795056283PROMO Screw Caddy Instruments Base (Use lid 3108-1)
00889795056276PROMO Screw Caddy Lid
00889795056269PROMO Screw Caddy Base (Use lid 3108-1)
00889795056252PROMO Case Base, Full Din
00889795056245PROMO Instrument Tray (Insert)
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