FDA.reportPublic FDA data

FX V135

Primary DI
00840452402713
Brand
FX V135
Company
FX Shoulder Solutions, Inc.
Model
950-6806
Device description
STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø40+6
Published
2025-08-26
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
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223801000FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.2023-06-05PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840452402713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840452402713008404524027138404524027130840452402713

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
115052068
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
00840452402485FX V135950-28092025-08-26
00840452402508FX V135950-28152025-08-26
00840452402515FX V135950-28182025-08-26
00840452402522FX V135950-38032025-08-26
00840452402539FX V135950-38062025-08-26
00840452402546FX V135950-38092025-08-26
00840452402553FX V135950-38122025-08-26
00840452402560FX V135950-38152025-08-26
00840452402577FX V135950-38182025-08-26
00840452402584FX V135950-48032025-08-26
00840452402591FX V135950-48062025-08-26
00840452402607FX V135950-48092025-08-26
00840452402614FX V135950-48122025-08-26
00840452402621FX V135950-48152025-08-26
00840452402638FX V135 950-48182025-08-26
00840452402645FX V135950-58032025-08-26
00840452402652FX V135950-58062025-08-26
00840452402669FX V135950-58092025-08-26
00840452402676FX V135950-58122025-08-26
00840452402683FX V135950-58152025-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097535678Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535692Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535715Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535739Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535753Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535777Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535791Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535814Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535838Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535852Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535876Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535890Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097534978Veritas rTSARestor3d, Inc.PHX2026-06-02
00840097534985Veritas rTSARestor3d, Inc.PHX2026-06-02
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.HSD2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWT2026-05-28
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07613327354874REUNIONStryker GmbHHSD2022-11-15
07613327354898REUNIONStryker GmbHHSD2022-11-15
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07613327355079REUNIONStryker GmbHHSD2022-11-15
07613327355116REUNIONStryker GmbHHSD2022-11-15
07613327355123REUNIONStryker GmbHHSD2022-11-15
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