INSERT UN-I XLG 11.5

Primary DI
M209103140
Brand
INSERT UN-I XLG 11.5
Company
BIOPRO, INC.
Model
10314
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
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890044000BIOPRO ANATOMIC UNICOMPARTMENTAL KNEEBiopro, Inc.1989-11-06HRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209103140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee insertA sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).

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
M209169570ACCU-CUT™ TWO STAGE169572015-09-16
M209169580ACCU-CUT™ TWO STAGE S169582015-09-16
M209173000ACCU-CUT™ 3mm OFFSET173002015-09-16
M209173060ACCU-CUT™ 3mm OFFSET S173062015-09-16
M209175020ACCU-CUT™ STANDARD W/2 BLADES175022015-09-16
M209175030ACCU-CUT™ 1mm OFFSET W/2 BLADES175032015-09-16
M209175040ACCU-CUT™ 2mm OFFSET W/2 BLADES175042015-09-16
M209175050ACCU-CUT™ 3mm OFFSET W/2 BLADES175052015-09-16
M209175060ACCU-CUT™ TWO STAGE W/2 BLADES175062015-09-16
M209177210ACCU-CUT™ STD MICRO CHOICE177212015-09-16
M209177330ACCU-CUT™ 1 mm MICRO CHOICE177332015-09-16
M209177340ACCU-CUT™ 2 mm MICRO CHOICE177342015-09-16
M209177350ACCU-CUT™ TWO STAGE MICRO177352015-09-16
M209185780ACCU-CUT™ 2mm W/THREADED K-WIRES185782015-09-16
M209195050ACCU-CUT™ STANDARD195052015-09-16
M209195060ACCU-CUT™ 1MM195062015-09-16
M209195070ACCU-CUT™ 2MM195072015-09-16
M209195080ACCU-CUT™ 3MM195082015-09-16
M209195090ACCU-CUT™ TWO STAGE195092015-09-16
M209195100ACCU-CUT™ LONG ARM195102015-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E31442411410SignatureMaterialise NVHRY2026-09-24
E31442422650SignatureMaterialise NVHRY2026-09-24
E31442422651SignatureMaterialise NVHRY2026-09-24
E31442422652SignatureMaterialise NVHRY2026-09-24
E31442422653SignatureMaterialise NVHRY2026-09-24
E31442422660SignatureMaterialise NVHRY2026-09-24
E31442422661SignatureMaterialise NVHRY2026-09-24
E31442422662SignatureMaterialise NVHRY2026-09-24
E31442422663SignatureMaterialise NVHRY2026-09-24
E31442422670SignatureMaterialise NVHRY2026-09-24
E31442422671SignatureMaterialise NVHRY2026-09-24
E31442422672SignatureMaterialise NVHRY2026-09-24
E31442422673SignatureMaterialise NVHRY2026-09-24
00192629082854EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082861EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082878EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082885EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082892EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082908EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082915EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082922EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082939EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082946EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082953EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082960EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082977EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082984EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082991EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629083004EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629083011EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18