FDA.reportPublic FDA data

Baby Gorilla/Gorilla Plating System

Primary DI
00889795040787
Brand
Baby Gorilla/Gorilla Plating System
Company
Paragon 28, Inc.
Model
P99-150-0011
Catalog number
P99-150-0011
Device description
Caspar Type Compression/Distraction Device
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
HWNINSTRUMENT, COMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795040787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795040787008897950407878897950407870889795040787

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy compression/distraction instrumentA non-sterile manual surgical instrument intended to be used for compression and distraction of an osteotomy. It is comprised of two arms that attach to pins/screws/nails inserted into both sides of the cut bone, and includes a mechanism (e.g., screw) used to close and open the arms of the device enabling compression and distraction at the osteotomy line. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795120199Paragon 28 Bone Wedge SystemAOCWO-16-5AOCWO-16-52023-06-26
00889795120632Paragon 28 Bone Wedge SystemAOLEW-22-12AOLEW-22-122023-04-04
00889795118523Paragon 28 Bone Wedge SystemAOCW-TRL-16-4.5AOCW-TRL-16-4.52022-10-14
00889795118530Paragon 28 Bone Wedge SystemAOCW-TRL-16-5.5AOCW-TRL-16-5.52022-10-14
00889795118547Paragon 28 Bone Wedge SystemAOCW-TRL-16-6.5AOCW-TRL-16-6.52022-10-14
00889795118554Paragon 28 Bone Wedge SystemAOCW-TRL-18-4.5AOCW-TRL-18-4.52022-10-14
00889795118561Paragon 28 Bone Wedge SystemAOCW-TRL-18-5.5AOCW-TRL-18-5.52022-10-14
00889795118578Paragon 28 Bone Wedge SystemAOCW-TRL-18-6.5AOCW-TRL-18-6.52022-10-14
00889795118585Paragon 28 Bone Wedge SystemAOCW-TRL-20-4.5AOCW-TRL-20-4.52022-10-14
00889795118592Paragon 28 Bone Wedge SystemAOCW-TRL-20-5.5AOCW-TRL-20-5.52022-10-14
00889795118608Paragon 28 Bone Wedge SystemAOCW-TRL-20-6.5AOCW-TRL-20-6.52022-10-14
00889795118615Paragon 28 Bone Wedge SystemAOEW-18-8 TRLAOEW-18-8 TRL2022-10-14
00889795118622Paragon 28 Bone Wedge SystemAOEW-18-10 TRLAOEW-18-10 TRL2022-10-14
00889795118639Paragon 28 Bone Wedge SystemAOEW-18-12 TRLAOEW-18-12 TRL2022-10-14
00889795118646Paragon 28 Bone Wedge SystemAOEW-20-8 TRLAOEW-20-8 TRL2022-10-14
00889795118653Paragon 28 Bone Wedge SystemAOEW-20-10 TRLAOEW-20-10 TRL2022-10-14
00889795118660Paragon 28 Bone Wedge SystemAOEW-20-12 TRLAOEW-20-12 TRL2022-10-14
00889795118677Paragon 28 Bone Wedge SystemAOEW-22-8 TRLAOEW-22-8 TRL2022-10-14
00889795118684Paragon 28 Bone Wedge SystemAOEW-22-10 TRLAOEW-22-10 TRL2022-10-14
00889795118691Paragon 28 Bone Wedge SystemAOEW-22-12 TRLAOEW-22-12 TRL2022-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083430009SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430047SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430078SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430092SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00840311251148Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251155Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251162Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251179Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251377Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311262953Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-27
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWN2026-03-30
00840311245451Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-03-18
00810111226691Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-02-20
00818345029774RIVA Posterior Fixation SystemXENIX MEDICAL LLCHWN2026-01-12
00810111226677Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226684Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226707Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
15060238201596Femoral Cement PressuriserSUMMIT MEDICAL LIMITEDHWN2025-01-10
00840298704637Songer® Spinal Cable SystemPioneer Surgical Technology, Inc.HWN2024-08-23
00841732164246GENERIC Surgical InstrumentsCTL Medical CorporationHWN2023-09-15
00841732164185GENERIC Surgical InstrumentsCTL Medical CorporationHWN2023-09-14
00643169350991Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWN2022-10-08
G079C5060000010Golden Isles Pedicle Screw SystemIntelivation, LLCHWN2022-09-23
00613994878137n/aMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
00721902875755N/AMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
20886982313437NASynthes GmbHHWN2022-07-29
20886982313444NASynthes GmbHHWN2022-07-29
20886982313451NASynthes GmbHHWN2022-07-29