FDA.reportPublic FDA data

CSB

Primary DI
10885862657046
Brand
CSB
Company
Exactech, Inc.
Model
321-52-68
Catalog number
321-52-68
Device description
CSB Cage Drill Pilot Tip, 0°
Published
2026-01-28
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
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233482000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233482000Equinoxe® Central Screw Baseplate SystemExactech, Inc.2024-07-18PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862657046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586265704610885862657046

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
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
10885862032102Novation160-20-11160-20-112015-08-10
10885862064035Optetrak244-24-09244-24-092015-10-30
10885862307132Truliant02-022-49-251102-022-49-25112017-05-16
10885862313058Optetrak Logic02-012-44-260902-012-44-26092017-02-16
10885862313065Optetrak Logic02-012-44-261102-012-44-26112017-02-16
10885862313072Optetrak Logic02-012-44-261302-012-44-26132017-02-16
10885862313089Optetrak Logic02-012-44-261502-012-44-26152017-02-16
10885862313218Optetrak Logic02-012-35-210902-012-35-21092017-02-16
10885862313225Optetrak Logic02-012-35-211102-012-35-21112017-02-16
10885862313232Optetrak Logic02-012-35-211302-012-35-21132017-02-16
10885862316271Optetrak Logic02-012-35-211702-012-35-21172017-02-16
10885862316288Optetrak Logic02-012-35-211902-012-35-21192017-02-16
10885862316356Optetrak Logic02-012-44-261702-012-44-26172017-02-16
10885862316363Optetrak Logic02-012-44-261902-012-44-26192017-02-16
10885862135049NAT2-5052T2-50522022-09-19
10885862135056NAT2-5458T2-54582022-09-19
10885862135063NAT2-6064T2-60642022-09-19
10885862135070NAT2-6670T2-66702022-09-19
10885862135636NAT8-4448T8-44482022-09-19
10885862135643NAT8-5052T8-50522022-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811596033460CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033477CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033484CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSKWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSPHX2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-09-22
00840097533919Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI208000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI220050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI220100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI226000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI228000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI246000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI248000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18