FDA.reportPublic FDA data

Baby Gorilla/Gorilla Plating System

Primary DI
00889795019769
Brand
Baby Gorilla/Gorilla Plating System
Company
Paragon 28, Inc.
Model
P51-900-0001
Catalog number
P51-900-0001
Device description
Baby Gorilla, Drill Guide, Threaded, Ø2.0 / 2.5, SS
Published
2019-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190365000Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.2019-04-12HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795019769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795019769008897950197698897950197690889795019769

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
042961576
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795038562Small Bone Phantom Intramedullary Nail SystemP30-196-2323P30-196-23232019-10-17
00889795118011Monkey Rings™ External Fixation SystemP45-511-0001P45-511-00012026-05-06
00889795152114Monkey Rings™ External Fixation SystemP45-113-0120P45-113-01202026-05-06
00889795152121Monkey Rings™ External Fixation SystemP45-113-0140P45-113-01402026-05-06
00889795152138Monkey Rings™ External Fixation SystemP45-113-0160P45-113-01602026-05-06
00889795152145Monkey Rings™ External Fixation SystemP45-113-0180P45-113-01802026-05-06
00889795152152Monkey Rings™ External Fixation SystemP45-113-0200P45-113-02002026-05-06
00889795152169Monkey Rings™ External Fixation SystemP45-113-0220P45-113-02202026-05-06
00889795152176Monkey Rings™ External Fixation SystemP45-191-4650P45-191-46502026-05-06
00889795152183Monkey Rings™ External Fixation SystemP45-191-5055P45-191-50552026-05-06
00889795152190Monkey Rings™ External Fixation SystemP45-191-5070P45-191-50702026-05-06
00889795152206Monkey Rings™ External Fixation SystemP45-191-6055P45-191-60552026-05-06
00889795152213Monkey Rings™ External Fixation SystemP45-191-6070P45-191-60702026-05-06
00889795152244Monkey Rings™ External Fixation SystemP45-196-4650P45-196-46502026-05-06
00889795152251Monkey Rings™ External Fixation SystemP45-196-5055P45-196-50552026-05-06
00889795152268Monkey Rings™ External Fixation SystemP45-196-5070P45-196-50702026-05-06
00889795152275Monkey Rings™ External Fixation SystemP45-196-6055P45-196-60552026-05-06
00889795152282Monkey Rings™ External Fixation SystemP45-196-6070P45-196-60702026-05-06
00889795152299Monkey Rings™ External Fixation SystemP45-197-2333P45-197-23332026-05-06
00889795152367Monkey Rings™ External Fixation SystemP45-334-1000P45-334-10002026-05-06

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008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
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