FDA.reportPublic FDA data

CSB

Primary DI
10885862657053
Brand
CSB
Company
Exactech, Inc.
Model
321-52-69
Catalog number
321-52-69
Device description
CSB Cage Drill Pilot Tip 8°, 10°, 8°/10°
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
10885862657053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586265705310885862657053

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
10885862088130Equinoxe321-98-08321-98-082022-10-04
10885862086075NA315-98-43315-98-432022-09-20
10885862086082NA315-98-44315-98-442022-09-20
10885862086099NA315-98-45315-98-452022-09-20
10885862086105NA315-98-46315-98-462022-09-20
10885862086112NA315-98-47315-98-472022-09-20
10885862086129NA315-98-48315-98-482022-09-20
10885862086136NA315-98-49315-98-492022-09-20
10885862086143NA315-98-50315-98-502022-09-20
10885862086150NA315-98-51315-98-512022-09-20
10885862086167NA315-98-52315-98-522022-09-20
10885862086174NA315-98-53315-98-532022-09-20
10885862086181NA315-98-54315-98-542022-09-20
10885862253620GPS521-78-03521-78-032022-09-19
10885862052162NA205-55-09205-55-092022-08-25
10885862052179NA205-55-11205-55-112022-08-25
10885862052186NA205-55-13205-55-132022-08-25
10885862052193NA205-55-15205-55-152022-08-25
10885862085733Equinoxe315-98-01315-98-012022-08-18
10885862085740Equinoxe315-98-02315-98-022022-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811596032036Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032050Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032067Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032074Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032081Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032098Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032104Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032111Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032128Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032135Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032142Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032159Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032166Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032173Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032180Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032197Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEPHX2026-08-03
00840097513119Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097513126Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097513133Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516004Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516011Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17