FDA.reportPublic FDA data

COPELAND SHOULDER SYSTEM

Primary DI
00880304204621
Brand
COPELAND SHOULDER SYSTEM
Company
Biomet Orthopedics, LLC
Model
11-114624
Catalog number
11-114624
Published
2015-10-24
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

Contact Domains#

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
K010657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010657000COPELAND MB RESURFACING HUMERAL HEADSBiomet Manufacturing, Inc.2001-09-14HSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304204621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304204621008803042046218803042046210880304204621

GMDN Terms#

Term, Definition table
TermDefinition
Coated 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 coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707726SolidLok®2810-01-0212810010212026-06-10
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315989ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315996ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037316009ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037316535ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037316542ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037316559ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037316566ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037300718HUMELOCKFX SOLUTIONSHSD2026-06-25
03701037307984HUMELOCKFX SOLUTIONSHSD2026-06-25
03701037308486ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-25
03701037308493ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-25
03701037308509ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-25
03701037310595Humeral Cup StandardFX SOLUTIONSHSD2026-06-25
03701037310601Humeral Cup StandardFX SOLUTIONSHSD2026-06-25
03701037311325ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-25
03701037311332ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-25
03701037311349ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-25
03701037311769ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-25
03701037311820Humelock IIFX SOLUTIONSHSD2026-06-25
03701037313763FX SOLUTIONSFX SOLUTIONSHSD2026-06-25