FDA.reportPublic FDA data

Bespa Charcot System

Primary DI
00810041320742
Brand
Bespa Charcot System
Company
Kapstone Manufacturing, LLC
Model
BSP01-3-1000
Device description
Surgical Tray-Charcot Axial Alignment and Segmental Column
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810041320742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041320742008100413207428100413207420810041320742

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCHWC2026-07-17
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07613327646856NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646863NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646870NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646887NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646894NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646900NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646917NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
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07613327647013NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647020NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647037NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647044NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647051NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647069NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647076NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647090NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647106NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
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37613327647120NAStryker Leibinger GmbH & Co. KGHWC2026-07-17