FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867409668
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-5410-VLS
Catalog number
AR-5410-VLS
Device description
VIP™ Glenoid Reamer, VaultLock® Small
Published
2023-04-24
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867409668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867409668008888674096688888674096680888867409668

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
DM exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867614956Arthrex®AR-S8457EXCAR-S8457EXC2026-05-25
00888867531949Arthrex®AR-8827H-22SAR-8827H-22S2026-03-16
00888867531970Arthrex®AR-8827H-28SAR-8827H-28S2026-03-16
00888867531987Arthrex®AR-8827H-30SAR-8827H-30S2026-03-16
00888867532014Arthrex®AR-8827H-36SAR-8827H-36S2026-03-16
00888867134874Arthrex®AR-9104-04AR-9104-042017-02-15
00888867336506Arthrex®AR-1593-4AR-1593-42019-12-13
00888867336520Arthrex®AR-1593DAR-1593D2019-12-13
00888867310209Arthrex®AR-4158TAR-4158T2019-11-15
00888867561687Arthrex®AR-2600FSF-1AR-2600FSF-12026-03-17
00888867561694Arthrex®AR-2600FSF-2AR-2600FSF-22026-03-17
00888867561700Arthrex®AR-2600FSF-3AR-2600FSF-32026-03-17
00888867463363Arthrex®AR-8974-02AR-8974-022026-03-16
00888867519459Arthrex®AR-8974FCAR-8974FC2026-03-16
00888867519473Arthrex®AR-8974FCLAR-8974FCL2026-03-16
00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
00888867519510Arthrex®AR-8974TLAR-8974TL2026-03-16
00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
00888867529045Arthrex®AR-8827H-12AR-8827H-122026-03-16
00888867529052Arthrex®AR-8827H-14AR-8827H-142026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024706828Mini Baseplate Sizer Cannulated HandleBiomet Orthopedics, LLCKWS2026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleBiomet Orthopedics, LLCKWS2026-03-19
10885862648549EquinoxeExactech, Inc.KWS2026-03-19
10885862648556EquinoxeExactech, Inc.KWS2026-03-19
10885862648563EquinoxeExactech, Inc.KWS2026-03-19
10885862656582EquinoxeExactech, Inc.KWS2026-02-09
00840338607669Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338607713Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338607720Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612342Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612366Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612373Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612380Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00889024692794Augmented BP Reamer Guide ExtractorBiomet Orthopedics, LLCKWS2025-12-18
00889024703742Versa-Dial® Shoulder SystemBiomet Orthopedics, LLCKWS2025-12-09
00885556919354AETOS Shoulder SystemSmith & Nephew, Inc.KWS2025-11-17
00889024691476Identity HumeralZimmer, Inc.KWS2025-09-22
00889024691445Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691490Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691599Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691605Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691612Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691629Identity HumeralZimmer, Inc.KWS2025-09-17
10885862657527EquinoxeExactech, Inc.KWS2025-09-09
10885862657534EquinoxeExactech, Inc.KWS2025-09-09
10885862657541EquinoxeExactech, Inc.KWS2025-09-09
10885862657558EquinoxeExactech, Inc.KWS2025-09-09
10885862657572EquinoxeExactech, Inc.KWS2025-09-09
10885862657602EquinoxeExactech, Inc.KWS2025-09-09
10885862657626EquinoxeExactech, Inc.KWS2025-09-09