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
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
00889795038562Small Bone Phantom Intramedullary Nail SystemP30-196-2323P30-196-23232019-10-17

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