FDA.reportPublic FDA data

Bun-Yo-Matic™ Lapidus Clamp System

Primary DI
00889795129413
Brand
Bun-Yo-Matic™ Lapidus Clamp System
Company
Paragon 28, Inc.
Model
P30-100-5310
Catalog number
P30-100-5310
Device description
Lapidus Nail Tissue Protector, Rotated 90
Published
2023-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
FZKChair, surgical, non-electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZKChair, Surgical, Non-ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795129413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795129413008897951294138897951294130889795129413

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042961576
Device count
1
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
14026704738981DEKNATELTELEFLEX INCORPORATEDFZK2025-09-04
24026704738988DEKNATELTELEFLEX INCORPORATEDFZK2025-09-04
00889024662155Pelvic Screw CannulaZimmer, Inc.FZK2023-12-15
00889024662162Pelvic Drill SleeveZimmer, Inc.FZK2023-12-15
00889024662179Pelvic Drill, 2.5mmZimmer, Inc.FZK2023-12-15
M368VIC429ST1HaustedGF HEALTH PRODUCTS, INC.FZK2020-10-09
M368APC250ST1HaustedGF HEALTH PRODUCTS, INC.FZK2020-10-07
M368MBC000ST1HaustedGF HEALTH PRODUCTS, INC.FZK2020-10-07
B06214501242Aries-L Lateral Lumbar Interbody SystemOsseus Fusion Systems, LLCFZK2020-05-12
10812608020239PMIPROGRESSIVE MEDICAL, INC.FZK2016-09-23