FDA.reportPublic FDA data

BioPro Bipolar Head 47mm

Primary DI
M209181390
Brand
BioPro Bipolar Head 47mm
Company
BIOPRO, INC.
Model
18139
Published
2015-09-16
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
K100761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100761000BIOPRO POLAR HEADBiopro, Inc.2010-12-03KWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209181390PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bipolar femoral head outer component, hemiarthroplastyAn implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618749857
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M209232580Hintermann Compressor232582026-05-22
M209232590Hintermann Distractor232592026-05-22
M20918608010mm HBS® Standard Compression186082015-09-16
M20918609011mm HBS® Standard Compression186092015-09-16
M20918610012mm HBS® Standard Compression186102015-09-16
M20918611013mm HBS® Standard Compression186112015-09-16
M20918612014mm HBS® Standard Compression186122015-09-16
M20918613015mm HBS® Standard Compression186132015-09-16
M20918614016mm HBS® Standard Compression186142015-09-16
M20918615017mm HBS® Standard Compression186152015-09-16
M20918616018mm HBS® Standard Compression186162015-09-16
M20918617019mm HBS® Standard Compression186172015-09-16
M20918618020mm HBS® Standard Compression186182015-09-16
M20918619021mm HBS® Standard Compression186192015-09-16
M20918620022mm HBS® Standard Compression186202015-09-16
M20918621023mm HBS® Standard Compression186212015-09-16
M20918622024mm HBS® Standard Compression186222015-09-16
M20918623025mm HBS® Standard Compression186232015-09-16
M20918624026mm HBS® Standard Compression186242015-09-16
M20918625027mm HBS® Standard Compression186252015-09-16

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