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
00889795038562Small Bone Phantom Intramedullary Nail SystemP30-196-2323P30-196-23232019-10-17
00889795118011Monkey Rings™ External Fixation SystemP45-511-0001P45-511-00012026-05-06
00889795152114Monkey Rings™ External Fixation SystemP45-113-0120P45-113-01202026-05-06
00889795152121Monkey Rings™ External Fixation SystemP45-113-0140P45-113-01402026-05-06
00889795152138Monkey Rings™ External Fixation SystemP45-113-0160P45-113-01602026-05-06
00889795152145Monkey Rings™ External Fixation SystemP45-113-0180P45-113-01802026-05-06
00889795152152Monkey Rings™ External Fixation SystemP45-113-0200P45-113-02002026-05-06
00889795152169Monkey Rings™ External Fixation SystemP45-113-0220P45-113-02202026-05-06
00889795152176Monkey Rings™ External Fixation SystemP45-191-4650P45-191-46502026-05-06
00889795152183Monkey Rings™ External Fixation SystemP45-191-5055P45-191-50552026-05-06
00889795152190Monkey Rings™ External Fixation SystemP45-191-5070P45-191-50702026-05-06
00889795152206Monkey Rings™ External Fixation SystemP45-191-6055P45-191-60552026-05-06
00889795152213Monkey Rings™ External Fixation SystemP45-191-6070P45-191-60702026-05-06
00889795152244Monkey Rings™ External Fixation SystemP45-196-4650P45-196-46502026-05-06
00889795152251Monkey Rings™ External Fixation SystemP45-196-5055P45-196-50552026-05-06
00889795152268Monkey Rings™ External Fixation SystemP45-196-5070P45-196-50702026-05-06
00889795152275Monkey Rings™ External Fixation SystemP45-196-6055P45-196-60552026-05-06
00889795152282Monkey Rings™ External Fixation SystemP45-196-6070P45-196-60702026-05-06
00889795152299Monkey Rings™ External Fixation SystemP45-197-2333P45-197-23332026-05-06
00889795152367Monkey Rings™ External Fixation SystemP45-334-1000P45-334-10002026-05-06

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