Biocore9 Humeral Resurfacing System

Primary DI
00810068850031
Brand
Biocore9 Humeral Resurfacing System
Company
Biocore9, LLC
Model
Humeral Resurfacing Component 52 mm
Catalog number
02-03-0052
Device description
Biocore9 Humeral Head Resurfacing Shoulder Component 52 mm
Published
2021-09-28
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193122000Biocore9 Humeral Resurfacing SystemBiocore9, LLC2020-05-15HSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810068850031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810068850031008100688500318100688500310810068850031

GMDN Terms#

Term, Definition table
TermDefinition
Resurfacing humeral head prosthesisA sterile implantable device designed to treat a disease-damaged (e.g., arthritic) shoulder joint by replacing the humeral articulating surface of the joint while preserving the natural humerus. It consists of a metallic humeral cap [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] that is placed over (resurfaces) a surgically-prepared humeral head, and may be used with a cementless stem.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter52Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093081548
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810068850017Biocore9 Humeral Resurfacing SystemHumeral Resurfacing Component 44 mm02-03-00442021-09-28
00810068850024Biocore9 Humeral Resurfacing SystemHumeral Resurfacing Component 48 mm02-03-00482021-09-28
00810068850048Biocore9 Humeral Resurfacing SystemHumeral Resurfacing Component 56 mm02-03-00562021-09-28
00810068850383Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 39.5 mm01-03-00392021-09-27
00810068850390Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 41 mm01-03-00412021-09-27
00810068850406Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 42.5 mm01-03-00422021-09-27
00810068850413Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 44 mm01-03-00442021-09-27
00810068850420Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 45.5 mm01-03-00452021-09-27
00810068850437Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 47 mm01-03-00472021-09-27
00810068850444Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 49 mm01-03-00492021-09-27
00810068850451Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 51 mm01-03-00512021-09-27
00810068850468Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 52.5 mm01-03-00522021-09-27

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Primary DI, Brand, Company table
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07613327668902Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668919Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668896Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
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