FDA.report

ENDURO

Primary DI
04046964010279
Brand
ENDURO
Company
Aesculap AG
Model
NR877M
Catalog number
NR877M
Device description
ENDURO MENISCAL COMPONENT F1 24MM
Published
2015-09-24
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

Related Records

Contact Domains

Product Codes

CodeName
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964010279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964010279040469640102794046964010279

GMDN Terms

TermDefinition
Rotating hinged total knee prosthesisA sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17
04038653038282AESCULAPDP540RDP540R2020-06-17
04038653038299AESCULAPDP541RDP541R2020-06-17
04038653038305AESCULAPDP542RDP542R2020-06-17
04038653177011AESCULAPOG961ROG961R2016-09-23
04038653251407AESCULAPOG960ROG960R2016-09-23
04038653044207MIASPAS MINI-ALIFFF569RFF569R2020-06-17
04038653044214MIASPAS MINI-ALIFFF571RFF571R2020-06-17
04038653044252MIASPAS MINI-ALIFFF578RFF578R2020-06-17
04038653044283MIASPAS MINI-ALIFFF586RFF586R2020-06-17
04038653117307AESCULAPNH196NH1962017-01-27
04038653117352AESCULAPNH206NH2062017-01-27
04038653118540AESCULAPNK088NK0882015-11-11
04038653118557AESCULAPNK089NK0892015-09-24
04038653118564AESCULAPNK090NK0902015-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00889024703278OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-09
00889024703308OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-09
00889024702011OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-05
00889024702028OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-05
00889024703285OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-02
00889024703322OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-02
04719872142812USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719872142829USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886893175USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886893182USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903560USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903577USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903584USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903591USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903607USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903614USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903621USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903638USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886908411USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908428USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908435USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908442USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908459USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908466USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908473USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908480USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908497USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908503USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908510USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908527USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08