FDA.reportPublic FDA data

Axis

Primary DI
00195411036929
Brand
Axis
Company
COLLEGE PARK INDUSTRIES, INC.
Model
SJ HPFK
Device description
Axis Shoulder Joint, Humeral Plate Fastener Kit
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQQJoint, Shoulder, External Limb Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQQJoint, Shoulder, External Limb ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195411036929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195411036929001954110369291954110369290195411036929

GMDN Terms#

Term, Definition table
TermDefinition
Passive shoulder prosthesisAn artificial substitute for a missing shoulder used as part of an upper-limb external prosthetic system and designed to be positioned by the application of external force.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-728-7950orders@college-park.com

Regulatory Flags#

DUNS number
623191137
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841747186936Aura PlusAHKA 5002026-01-29
00841747186943Aura PlusAHKA 5502026-01-29
00195411458905IconIC CB G2025-05-28
00841747186912Endoskeletal ComponentsTA WT250 302025-05-28
00841747186929Endoskeletal ComponentsTA WT430 302025-05-28
00841747183973SterlingSLK G3L US12024-11-01
00841747183997SterlingSLK G3C UL22024-11-01
00841747184000SterlingSLK G3C UM+22024-11-01
00841747184017SterlingSLK G3C UM22024-11-01
00841747184024SterlingSLK G3C US22024-11-01
00841747184031SterlingSLK G9L UXL22024-11-01
00841747184048SterlingSLK G9L UL+22024-11-01
00841747184055SterlingSLK G9L UL22024-11-01
00841747184062SterlingSLK G9L UM+22024-11-01
00841747184079SterlingSLK G9L UM22024-11-01
00841747184086SterlingSLK G9L US22024-11-01
00841747184093SterlingSLK G6L UXL22024-11-01
00841747184109SterlingSLK G6L UL+22024-11-01
00841747184116SterlingSLK G6L UL22024-11-01
00841747184123SterlingSLK G6L UM+22024-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071315509TrendOrthofix US LLCIQQ2026-04-25
00850071315516TrendOrthofix US LLCIQQ2026-04-25
00850071315486TrendOrthofix US LLCIQQ2026-04-23
00850071315493TrendOrthofix US LLCIQQ2026-04-23
00810113683539ManaEZ Shoulder Ice CureTechManamed, Inc.IQQ2025-10-03
08936235650005Fullerton Manufacturing LimitedFULLERTON MANUFACTURING LIMITEDIQQ2025-07-02
04719883461698TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883463432TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883463449TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883463456TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883463463TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464286TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464859TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464866TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464873TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464880TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
00810179880958CopperfitIdeavillage Products CorpIQQ2024-11-18
00810179880965CopperfitIdeavillage Products CorpIQQ2024-11-18
00850012035312Unite Medical®Unite Medical, LLCIQQ2024-06-20
00749756394734DeRoyalDEROYAL INDUSTRIES, INC.IQQ2024-06-06
50749756394739DeRoyalDEROYAL INDUSTRIES, INC.IQQ2024-06-06
04719883460165TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460523TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460554TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460608TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460622TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460660TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460714TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460745TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460912TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31