FDA.reportPublic FDA data

Humelock II Cemented Reversible Shoulder

Primary DI
03701037300213
Brand
Humelock II Cemented Reversible Shoulder
Company
FX SOLUTIONS
Model
105-0006
Catalog number
105-0006
Device description
POST EXTENSION TA6V +06 mm CEMENTLESS Ti/HA
Published
2016-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

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
03701037300213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701037300213037010373002133701037300213

GMDN Terms#

Term, Definition table
TermDefinition
Humeral body extension prosthesisA sterile implantable component of a reverse shoulder prosthesis that consists of a metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] piece intended to function as a spacer between a reverse shoulder body prosthesis and a reverse shoulder cup prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Millimeter

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

Contacts#

Phone, Email table
PhoneEmail
+33474553397jjmartin@fxsolutions.fr

Regulatory Flags#

DUNS number
263076196
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701037320440FX V135 Shoulder Prosthesis906-0029906-00292026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENT906-0061906-00612026-09-22
03701037320433ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-0074951-00742026-08-17
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENT961-0017961-00172026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8803951-88032026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8806951-88062026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8809951-88092026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8812951-88122026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8815951-88152026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8818951-88182026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9803951-98032026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9806951-98062026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9809951-98092026-06-26
03701037315989ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9812951-98122026-06-26
03701037315996ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9815951-98152026-06-26
03701037316009ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9818951-98182026-06-26
03701037316535ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9909951-99092026-06-26
03701037316542ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9912951-99122026-06-26
03701037316559ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9915951-99152026-06-26
03701037316566ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9918951-99182026-06-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07630699706056Shoulder SystemMedacta International SAPHX2026-10-01
B1132R2HC300100Shoulder Innovations RSA Glenosphere Trial Instrument CaseShoulder Innovations, Inc.PHX2026-09-30
07630345775320Shoulder SystemMedacta International SAPHX2026-09-28
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