FDA.reportPublic FDA data

Aura

Primary DI
10885862015341
Brand
Aura
Company
Exactech, Inc.
Model
107-05-14
Catalog number
107-05-14
Device description
AURA LG STEM REAMER SZ 4
Published
2022-08-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961304000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961304000AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEMExactech, Inc.1996-10-01JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862015341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586201534110885862015341

GMDN Terms#

Term, Definition table
TermDefinition
Medullary canal orthopaedic reamer, rigidAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862032102Novation160-20-11160-20-112015-08-10
10885862064035Optetrak244-24-09244-24-092015-10-30
10885862307132Truliant02-022-49-251102-022-49-25112017-05-16
10885862313058Optetrak Logic02-012-44-260902-012-44-26092017-02-16
10885862313065Optetrak Logic02-012-44-261102-012-44-26112017-02-16
10885862313072Optetrak Logic02-012-44-261302-012-44-26132017-02-16
10885862313089Optetrak Logic02-012-44-261502-012-44-26152017-02-16
10885862313218Optetrak Logic02-012-35-210902-012-35-21092017-02-16
10885862313225Optetrak Logic02-012-35-211102-012-35-21112017-02-16
10885862313232Optetrak Logic02-012-35-211302-012-35-21132017-02-16
10885862316271Optetrak Logic02-012-35-211702-012-35-21172017-02-16
10885862316288Optetrak Logic02-012-35-211902-012-35-21192017-02-16
10885862316356Optetrak Logic02-012-44-261702-012-44-26172017-02-16
10885862316363Optetrak Logic02-012-44-261902-012-44-26192017-02-16
10885862135049NAT2-5052T2-50522022-09-19
10885862135056NAT2-5458T2-54582022-09-19
10885862135063NAT2-6064T2-60642022-09-19
10885862135070NAT2-6670T2-66702022-09-19
10885862135636NAT8-4448T8-44482022-09-19
10885862135643NAT8-5052T8-50522022-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629032071LineageMicroport Orthopedics Inc.JDI2026-08-18
00192629031937LineageMicroport Orthopedics Inc.JDI2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14