FDA.reportPublic FDA data

B-P TOTAL HIP SYSTEM

Primary DI
00814193024763
Brand
B-P TOTAL HIP SYSTEM
Company
ENDOTEC, INC.
Model
01-21-0109
Catalog number
01-21-0109
Device description
B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 9 MM
Published
2015-09-17
Public version status
Update
Distribution status
Not 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
K884789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884789000NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLIProtek, Inc.1989-02-08KWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814193024763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814193024763008141930247638141930247630814193024763

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
Width9Millimeter

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011453476REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453483REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453490REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
04026575047758Endo-Model Saddle ProsthesisWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575047772Endo-Model Saddle ProsthesisWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575047789Endo-Model Saddle ProsthesisWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575047796Endo-Model Saddle ProsthesisWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575047802Endo-Model Saddle ProsthesisWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575047819Endo-Model Saddle ProsthesisWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575047826Endo-Model Saddle ProsthesisWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575047833Endo-Model Saddle ProsthesisWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575047857Endo-Model Saddle ProsthesisWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575047864Endo-Model Saddle ProsthesisWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348213SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348220SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348237SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348244SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348251SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348268SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348275SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348282SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348299SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348305SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348350SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348367SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348374SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01
04026575348381SPII Model LubinusWALDEMAR LINK GmbH & Co. KGKWL2015-11-01