FDA.reportPublic FDA data

Humelock II Cemented Reversible Shoulder

Primary DI
03701037313992
Brand
Humelock II Cemented Reversible Shoulder
Company
FX SOLUTIONS
Model
913-0703-CM1
Catalog number
913-0703-CM1
Device description
STANDARD TRIAL HUMERAL CUP CUSTOM MADE 135/145° Ø36 +3
Published
2020-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150488000Humelock II Reversible Shoulder SystemFx Solutions2015-11-13PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701037313992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701037313992037010373139923701037313992

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from light and sunlight Store away from moisture

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
263076196
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701037303740HUMELOCK REVERSEDØ36/12 CEMENTLESS LOCKABLE317-36122017-01-31
03701037303092PRCT2100-0008100-00082016-06-08
03701037303108PRCT2100-0009100-00092016-06-08
03701037303115PRCT2100-0010100-00102016-06-08
03701037303139PRCT2100-0012100-00122016-06-08
03701037303160PRCT2100-0109100-01092016-06-08
03701037303177PRCT2100-0110100-01102016-06-08
03701037303184PRCT2100-0111100-01112016-06-08
03701037303191PRCT2100-0112100-01122016-06-08
03701037303207PRCT2100-0113100-01132016-06-08
03701037305843Humelock Reversed Shoulder903-0006903-00062018-09-27
03701037305850Humelock Reversed Shoulder903-0009-01903-0009-012018-09-27
03701037305867Humelock Reversed Shoulder903-0009-02903-0009-022018-09-27
03701037305911Humelock Reversed Shoulder903-0018903-00182018-09-27
03701037305782Humelock II Cemented Shoulder System902-0334902-03342018-09-27
03701037305799Humelock II Cemented Shoulder System902-0400902-04002018-09-27
03701037305805Humelock II Cemented Shoulder System902-0500902-05002018-09-27
03701037306406Humelock II Cemented Reversible Shoulder908-0055908-00552018-09-27
03701037311776Humelock II926-10412025-08-01
03701037311783Humelock II926-10422025-08-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816127027215InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
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00816127027253InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00843511128777Omnia Medical TiBrid™-A/SAOMNIA MEDICAL, LLCLXH2026-06-01
00857915007712ObturatorA.M. SURGICAL, INC.LXH2026-06-01
00857915007729CannulaA.M. SURGICAL, INC.LXH2026-06-01
00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
07899258648729Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mmShukla MedicalLXH2026-06-01
10884450587727PowerCURVE®Merit Medical Systems, Inc.LXH2026-05-30
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07630542799051Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542799068Surgical Manual InstrumentMedacta International SALXH2026-05-29
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