FDA.report

Bespa Charcot System

Primary DI
00810041320346
Brand
Bespa Charcot System
Company
Kapstone Manufacturing, LLC
Model
BSP01-1-1501
Catalog number
BSP01-1-1501
Device description
Seg Column, Distal
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810041320346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041320346008100413203468100413203460810041320346

GMDN Terms

TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
074092521
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810041320179Bespa Charcot SystemBSP01-2-1506BSP01-2-15062023-02-28
00810041320186Bespa Charcot SystemBSP01-2-1507BSP01-2-15072023-02-28
00810041320278Bespa Charcot SystemBSP01-2-1508BSP01-2-15082023-02-28
00810041320292Bespa Charcot SystemBSP01-2-1509BSP01-2-15092023-02-28
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
00810041320742Bespa Charcot SystemBSP01-3-10002023-02-28
00810041320759Bespa Charcot SystemBSP01-9-2012BSP01-9-20122023-02-28
00810041320001Bespa Charcot SystemBSP01-9-9000BSP01-9-90002023-02-16
00810041320193Bespa Charcot SystemBSP01-2-1505BSP01-2-15052023-02-16
00810041320209Bespa Charcot SystemBSP01-2-1513BSP01-2-15132023-02-16
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
00810041320254Bespa Charcot SystemBSP01-6-1501-02BSP01-6-1501-022023-02-16
00810041320261Bespa Charcot SystemBSP01-2-1502BSP01-2-15022023-02-16

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