FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327511956
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
6278-8-321
Catalog number
6278-8-321
Device description
RESTORATION MODULAR INST SYS CONICAL DISTAL REAMER
Published
2022-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327511956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327511956076133275119567613327511956

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
058311945
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327012804V40 Head6260-4-2226260-4-2222015-09-24
07613327012811V40 Head6260-4-3226260-4-3222015-09-24
07613327012828V40 Head6260-5-0266260-5-0262015-09-24
07613327012835V40 Head6260-5-0286260-5-0282015-09-24
07613327012842V40 Head6260-5-0326260-5-0322015-09-24
07613327012859V40 Head6260-5-1266260-5-1262015-09-24
07613327012866V40 Head6260-5-1286260-5-1282015-09-24
07613327012873V40 Head6260-5-1326260-5-1322015-09-24
07613327012880V40 Head6260-5-2266260-5-2262015-09-24
07613327012897V40 Head6260-5-2286260-5-2282015-09-24
07613327012903V40 Head6260-5-2326260-5-2322015-09-24
07613327012941V40 Head6260-5-4266260-5-4262015-09-24
07613327012958V40 Head6260-5-4286260-5-4282015-09-24
07613327012965V40 Head6260-5-4326260-5-4322015-09-24
07613327012972V40 Head6260-5-6286260-5-6282015-09-24
07613327019704Restoration5096-46255096-46252015-09-24
07613327019711Restoration5096-46155096-46152015-09-24
07613327019728Restoration5096-46205096-46202015-09-24
07613327019735Restoration5096-50155096-50152015-09-24
07613327019742Restoration5096-50205096-50202015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327380392TRIDENT IIHowmedica Osteonics Corp.MEH2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.LPH2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.JDI2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.LZO2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.KWZ2018-02-12
07613327345001Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.LZO2016-10-20