FDA.reportPublic FDA data

Bespa Charcot System

Primary DI
00810041320445
Brand
Bespa Charcot System
Company
Kapstone Manufacturing, LLC
Model
BSP01-2-1504
Catalog number
BSP01-2-1504
Device description
Seg Col Drill Cap
Published
2023-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810041320445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041320445008100413204458100413204450810041320445

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
074092521
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810041320346Bespa Charcot SystemBSP01-1-1501BSP01-1-15012023-02-28
00810041320353Bespa Charcot SystemBSP01-1-1502-02BSP01-1-1502-022023-02-28
00810041320360Bespa Charcot SystemBSP01-1-1502-10BSP01-1-1502-102023-02-28
00810041320377Bespa Charcot SystemBSP01-1-1502-20BSP01-1-1502-202023-02-28
00810041320384Bespa Charcot SystemBSP01-1-1503BSP01-1-15032023-02-28
00810041320452Bespa Charcot SystemBSP01-1-1504BSP01-1-15042023-02-28
00810041320391Bespa Charcot SystemBSP01-1-1505-45BSP01-1-1505-452023-02-16
00810041320407Bespa Charcot SystemBSP01-1-1505-50BSP01-1-1505-502023-02-16
00810041320414Bespa Charcot SystemBSP01-1-1505-60BSP01-1-1505-602023-02-16
00810041320421Bespa Charcot SystemBSP01-1-1505-70BSP01-1-1505-702023-02-16
00810041320469Bespa Charcot SystemBSP01-1-1505-15BSP01-1-1505-152023-02-16
00810041320476Bespa Charcot SystemBSP01-1-1505-20BSP01-1-1505-202023-02-16
00810041320483Bespa Charcot SystemBSP01-1-1505-25BSP01-1-1505-252023-02-16
00810041320490Bespa Charcot SystemBSP01-1-1505-30BSP01-1-1505-302023-02-16
00810041320506Bespa Charcot SystemBSP01-1-1505-35BSP01-1-1505-352023-02-16
00810041320513Bespa Charcot SystemBSP01-1-1505-40BSP01-1-1505-402023-02-16
00810041320216Bespa Charcot SystemBSP01-6-1501-04BSP01-6-1501-042023-02-16
00810041320223Bespa Charcot SystemBSP01-6-1501-05BSP01-6-1501-052023-02-16
00810041320230Bespa Charcot SystemBSP01-2-1511BSP01-2-15112023-02-16
00810041320247Bespa Charcot SystemBSP01-6-1501-06BSP01-6-1501-062023-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982350633VOLTSynthes GmbHFZX2026-09-25
10886982350640VOLTSynthes GmbHFZX2026-09-25
10886982350657VOLTSynthes GmbHFZX2026-09-25
10886982350664VOLTSynthes GmbHFZX2026-09-25
10886982350671VOLTSynthes GmbHFZX2026-09-25
10886982350688VOLTSynthes GmbHFZX2026-09-25
10886982351098VOLTSynthes GmbHFZX2026-09-25
10886982351104VOLTSynthes GmbHFZX2026-09-25
10886982351111VOLTSynthes GmbHFZX2026-09-25
10886982351128VOLTSynthes GmbHFZX2026-09-25
10886982351135VOLTSynthes GmbHFZX2026-09-25
10886982351142VOLTSynthes GmbHFZX2026-09-25
10886982351692VOLTSynthes GmbHFZX2026-09-25
10886982357182VOLTSynthes GmbHFZX2026-09-25
00190776432164MillenniumAvalign Technologies, Inc.FZX2026-09-22
00810111228527Drill GuideTreace Medical Concepts, Inc.FZX2026-09-21
00190776423896MillenniumAvalign Technologies, Inc.FZX2026-08-26
10886982362988NASynthes GmbHFZX2026-08-26
10886982362995NASynthes GmbHFZX2026-08-26
10886982363008NASynthes GmbHFZX2026-08-26
10886982363015NASynthes GmbHFZX2026-08-26
008890247114712.9 JuggerKnot Self-Punching ObturatorZimmer, Inc.FZX2026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaZimmer, Inc.FZX2026-08-25
00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
06937278653598CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653604CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653611CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653628CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654250CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654267CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22