FDA.reportPublic FDA data

ENDO MD 51

Primary DI
M209101850
Brand
ENDO MD 51
Company
BIOPRO, INC.
Model
10185
Published
2015-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K895886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895886000BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEMBiopro, Inc.1989-12-01KWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209101850PrimaryHIBCC0

Regulatory Flags#

DUNS number
618749857
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M209101790ENDO MD 38101792015-09-16
M209101800ENDO MD 41101802015-09-16
M209101820ENDO MD 45101822015-09-16
M209101830ENDO MD 47101832015-09-16
M209101840ENDO MD 49101842015-09-16
M209101860ENDO MD 53101862015-09-16
M209101870ENDO MD 55101872015-09-16
M209101880ENDO SH 38101882015-09-16
M209101890ENDO SH 41101892015-09-16
M209101900ENDO SH 43101902015-09-16
M209101910ENDO SH 45101912015-09-16
M209101920ENDO SH 47101922015-09-16
M209101930ENDO SH 49101932015-09-16
M209101940ENDO SH 51101942015-09-16
M209101950ENDO SH 53101952015-09-16
M209101960ENDO SH 55101962015-09-16
M209130070ENDO MODULAR CERAMIC SH 41130072015-09-16
M209130080ENDO MODULAR CERAMIC SH 43130082015-09-16
M209130090ENDO MODULAR CERAMIC SH 45130092015-09-16
M209130100ENDO MODULAR CERAMIC SH 47130102015-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056885860InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885884InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885907InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885921InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885945InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885969InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885983InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886003InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886027InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886041InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886065InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22