FDA.reportPublic FDA data

Baby Gorilla/Gorilla Plating System

Primary DI
00889795039842
Brand
Baby Gorilla/Gorilla Plating System
Company
PARAGON 28, INC.
Model
P51-920-1004
Catalog number
P51-920-1004
Device description
BOW & ARROW Osteotome, Single Taper
Published
2019-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWMOSTEOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795039842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795039842008897950398428897950398420889795039842

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
042961576
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795153845Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-1P50-900-BGSL-12026-02-19
00889795153852Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-2P50-900-BGSL-22026-02-19
00889795153883Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-3P50-900-BGSL-32026-02-19
00889795153890Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-4P50-900-BGSL-42026-02-19
00889795153906Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-1P50-900-SBSL-12026-02-19
00889795153913Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-2P50-900-SBSL-22026-02-19
00889795153944Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-3P50-900-SBSL-32026-02-19
00889795153951Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-4P50-900-SBSL-42026-02-19
00889795153968Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-5P50-900-SBSL-52026-02-19
00889795153975Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-6P50-900-SBSL-62026-02-19
00889795153982Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-7P50-900-SBSL-72026-02-19
00889795153999Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-5P50-900-BGSL-52026-02-19
00889795154002Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-6P50-900-BGSL-62026-02-19
00889795154019Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-7P50-900-BGSL-72026-02-19
00889795154026APEX 3D Total Ankle Replacement SystemP10-844-FTPPP10-844-FTPP2026-02-19
00889795153661Precision MIS Bunion SystemP27-200-1000P27-200-10002026-02-06
00889795128737Baby Gorilla/Gorilla Plating SystemP99-151-P51L-SP99-151-P51L-S2026-01-29
00889795110879APEX 3D Total Ankle Replacement SystemP99-151-P105-1-SP99-151-P105-1-S2026-01-28
00889795118400APEX 3D Total Ankle Replacement SystemP99-152-P104-SP99-152-P104-S2026-01-28
00889795118417APEX 3D Total Ankle Replacement SystemP99-152-P105-SP99-152-P105-S2026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800270Adler Instrument CompanyAdler, Inc.HWM2026-05-26
00810220800287Adler Instrument CompanyAdler, Inc.HWM2026-05-26
10885862663238N/AExactech, Inc.HWM2026-03-19
00190776417796MillenniumAvalign Technologies, Inc.HWM2026-03-11
00190776417802MillenniumAvalign Technologies, Inc.HWM2026-03-11
M9307867516310Life InstrumentsLife Instrument CorporationHWM2026-03-06
00840319758861Hayden MedicalHayden Medical, Inc.HWM2026-03-05
00840319758878Hayden MedicalHayden Medical, Inc.HWM2026-03-05
00190776417611MillenniumAvalign Technologies, Inc.HWM2026-03-04
04046826118327MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWM2026-02-27
04046826118341MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWM2026-02-27
03662663109598Mergence-A Preparation InstrumentationHighridge Medical, LLCHWM2026-02-11
03662663131780Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWM2026-02-11
10886982361295NASynthes GmbHHWM2026-02-11
00840277133243Innomed, Inc.INNOMED, INC.HWM2026-02-06
00840277133250Innomed, Inc.INNOMED, INC.HWM2026-02-06
03662663084079ActivLHighridge Medical, LLCHWM2026-02-03
00190776415464MillenniumAvalign Technologies, Inc.HWM2026-01-27
03662663155786Zyston Interbody Spacer SystemHighridge Medical, LLCHWM2025-12-29
03662663155809Zyston Interbody Spacer SystemHighridge Medical, LLCHWM2025-12-29
03662663216005Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216012Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216241Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216258Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216265Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216319Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216326Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216333Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216340Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216357Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17