FDA.reportPublic FDA data

Baby Gorilla®/Gorilla® Plating System

Primary DI
00889795146137
Brand
Baby Gorilla®/Gorilla® Plating System
Company
Paragon 28, Inc.
Model
P51-926-4001
Catalog number
P51-926-4001
Device description
Pilon Fusion, King Cobra Cartilage Removal Tool
Published
2025-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795146137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795146137008897951461378897951461370889795146137

GMDN Terms#

Term, Definition table
TermDefinition
Cartilage knifeA hand-held manual surgical instrument designed for cutting, shaving or shaping cartilage during a surgical intervention. It is typically a one-piece instrument with a sharp, single-edged, cutting blade at the distal end which is normally very long, similar in shape to a scalpel blade, and may vary in length and size; it has a handle at the proximal end. It is normally made of high-grade stainless steel. Also known as a chondrotome, a cartilage knife can also be used in pathology procedures. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042961576
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795097972Phantom Hindfoot TTC/TC Nail SystemP31-955-1550P31-955-15502020-12-15
00889795154668Primal OCDP69-900-0004-SKP69-900-0004-SK2026-07-14
00889795154675Primal OCDP69-900-0006-SKP69-900-0006-SK2026-07-14
00889795154682Primal OCDP69-900-0008-SKP69-900-0008-SK2026-07-14
00889795154507Spider Monkey Bone Transport SystemP38-300-2810P38-300-28102026-06-10
00889795154514Spider Monkey Bone Transport SystemP38-300-2410P38-300-24102026-06-10
00889795154521Spider Monkey Bone Transport SystemP38-300-3210P38-300-32102026-06-10
00889795154538Spider Monkey Bone Transport SystemP38-900-0001P38-900-00012026-06-10
00889795154545Spider Monkey Bone Transport SystemP38-900-0002P38-900-00022026-06-10
00889795154552Spider Monkey Bone Transport SystemP38-910-0001P38-910-00012026-06-10
00889795154569Spider Monkey Bone Transport SystemP38-910-0002P38-910-00022026-06-10
00889795154576Spider Monkey Bone Transport SystemP38-910-0003P38-910-00032026-06-10
00889795154583Spider Monkey Bone Transport SystemP38-900-BONBP38-900-BONB2026-06-10
00889795154590Spider Monkey Bone Transport SystemP38-900-BONLP38-900-BONL2026-06-10
00889795154606Spider Monkey Bone Transport SystemP38-300-4016P38-300-40162026-06-10
00889795154613Spider Monkey Bone Transport SystemP38-900-0003P38-900-00032026-06-10
00889795154620Spider Monkey Bone Transport SystemP38-210-320BP38-210-320B2026-06-10
00889795154637Spider Monkey Bone Transport SystemP38-210-420BP38-210-420B2026-06-10
00889795154644Spider Monkey Bone Transport SystemP38-211-320BP38-211-320B2026-06-10
00889795154651Spider Monkey Bone Transport SystemP38-211-420BP38-211-420B2026-06-10

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Primary DI, Brand, Company table
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00810135961271ToejackNVision Biomedical Technologies, Inc.LXH2026-07-24
00840314263261gSourceGSOURCE LLCLXH2026-07-24
00840314263278gSourceGSOURCE LLCLXH2026-07-24
00840314263285gSourceGSOURCE LLCLXH2026-07-24
00840314263353gSourceGSOURCE LLCLXH2026-07-24
00840314263421gSourceGSOURCE LLCLXH2026-07-24
00840314263704gSourceGSOURCE LLCLXH2026-07-24
00840314263773gSourceGSOURCE LLCLXH2026-07-24
00840314263841gSourceGSOURCE LLCLXH2026-07-24
00889024709195DRILL MEASURING SLEEVEBiomet Orthopedics, LLCLXH2026-07-24
07640221373694SCALASpineArt SALXH2026-07-24
07640221373700SCALASpineArt SALXH2026-07-24
10886982362179NASynthes GmbHLXH2026-07-24
B382SD9141071020Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071040Surgical DirectSurgical Direct, Inc.LXH2026-07-24
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00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
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00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21