FDA.reportPublic FDA data

Preserve Bone Wedge Trials

Primary DI
00889795146588
Brand
Preserve Bone Wedge Trials
Company
Paragon 28, Inc.
Model
PCT-3DP-0010
Catalog number
PCT-3DP-0010
Device description
3D Printed Cotton Trial, 10mm
Published
2025-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795146588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795146588008897951465888897951465880889795146588

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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
00889795135278Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-1P50-900-AFSL-12026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-2P50-900-AFSL-22026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-3P50-900-AFSL-32026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-4P50-900-AFSL-42026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-5P50-900-AFSL-52026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-6P50-900-AFSL-62026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-7P50-900-AFSL-72026-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982350596VOLTSynthes GmbHHWT2026-09-25
10886982350602VOLTSynthes GmbHHWT2026-09-25
10886982350619VOLTSynthes GmbHHWT2026-09-25
10886982350626VOLTSynthes GmbHHWT2026-09-25
10886982350695VOLTSynthes GmbHHWT2026-09-25
10886982350701VOLTSynthes GmbHHWT2026-09-25
10886982350718VOLTSynthes GmbHHWT2026-09-25
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
10888857298590ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298606ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298613ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298620ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298637ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298644ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298651ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298668ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298675ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298682ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298699ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298705ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298712ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298729ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857562332K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562349K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562356K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562363K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562370K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562387K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562394K2M General InstrumentsVB Spine LLCHWT2023-09-08