FDA.reportPublic FDA data

B-P TOTAL HIP SYSTEM

Primary DI
00814193023322
Brand
B-P TOTAL HIP SYSTEM
Company
ENDOTEC, INC.
Model
01-17-2842
Catalog number
01-17-2842
Device description
B-P HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 42 MM O.D.
Published
2015-09-17
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
KWLProsthesis, Hip, Hemi-, Femoral, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884889000MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.Protek, Inc.1989-02-27KWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814193023322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814193023322008141930233228141930233220814193023322

GMDN Terms#

Term, Definition table
TermDefinition
Humeral head bipolar componentA sterile, implantable, hemisphere-shaped component of a bipolar partial shoulder prosthesis designed to interface with the glenoid fossa on its outer surface where it freely rotates, and interface with a humeral head prosthesis on its inner surface where it allows free rotation of the head. It is typically composed of an outer metal shell and an inner polyethylene (PE) liner.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter28Millimeter
Outer Diameter42Millimeter

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
803488357
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814193020017B-P TOTAL KNEE SYSTEM04-31-200104-31-20012015-09-17
00814193020031B-P TOTAL KNEE SYSTEM04-31-200204-31-20022015-09-17
00814193020062B-P TOTAL KNEE SYSTEM04-31-100404-31-10042015-09-17
00814193020116B-P TOTAL KNEE SYSTEM04-31-200604-31-20062015-09-17
00814193020253B-P TOTAL KNEE SYSTEM04-31-220104-31-22012015-09-17
00814193020505B-P TOTAL KNEE SYSTEM04-31-150204-31-15022015-09-17
00814193020529B-P TOTAL KNEE SYSTEM04-31-150304-31-15032015-09-17
00814193020536B-P TOTAL KNEE SYSTEM04-31-250304-31-25032015-09-17
00814193020543B-P TOTAL KNEE SYSTEM04-31-150404-31-15042015-09-17
00814193020574B-P TOTAL KNEE SYSTEM04-31-250504-31-25052015-09-17
00814193020581B-P TOTAL KNEE SYSTEM04-31-150604-31-15062015-09-17
00814193020628B-P TOTAL KNEE SYSTEM04-32-000304-32-00032015-09-17
00814193020666B-P TOTAL KNEE SYSTEM04-32-001104-32-00112015-09-17
00814193020673B-P TOTAL KNEE SYSTEM04-32-001204-32-00122015-09-17
00814193020710B-P TOTAL KNEE SYSTEM04-32-001604-32-00162015-09-17
00814193020734B-P TOTAL KNEE SYSTEM04-32-002204-32-00222015-09-17
00814193020789B-P TOTAL KNEE SYSTEM04-32-006104-32-00612015-09-17
00814193020802B-P TOTAL KNEE SYSTEM04-32-006304-32-00632015-09-17
00814193020826B-P TOTAL KNEE SYSTEM04-32-006504-32-00652015-09-17
00814193020833B-P TOTAL KNEE SYSTEM04-32-006604-32-00662015-09-17

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Primary DI, Brand, Company table
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