FDA.reportPublic FDA data

Humelock Reversed Shoulder

Primary DI
03701037301388
Brand
Humelock Reversed Shoulder
Company
FX SOLUTIONS
Model
313-3206
Catalog number
313-3206
Device description
HUMELOCK REVERSED STEM TA6V CEMENTED Ø32/06
Published
2017-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162455000Humelock Reversed ShoulderFx Solutions2017-01-17PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701037301388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701037301388037010373013883701037301388

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated shoulder humeral stem prosthesisA sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6Millimeter
Outer Diameter32Millimeter

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

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
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

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
07613327354379REUNIONStryker GmbHHSD2022-11-15
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07613327354980REUNIONStryker GmbHHSD2022-11-15
07613327355079REUNIONStryker GmbHHSD2022-11-15
07613327355116REUNIONStryker GmbHHSD2022-11-15
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