FDA.reportPublic FDA data

NEOFUSE

Primary DI
03760225717059
Brand
NEOFUSE
Company
IN2BONES
Model
P02 00131
Catalog number
P02 00131
Device description
DRILL DIAM 3.2 MM LG200 MM HIND FOOT PLATE
Published
2020-06-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173121000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173121000Ankle Fusion Plating SystemIn2bones Sas2017-11-28HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760225717059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760225717059037602257170593760225717059

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, reusableA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
263616749
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701337614355QUANTUMM05 PSIM05 PSI2024-12-13
03760225715499Kirschner wireK20 NS150K20 NS1502016-03-18
03760225710968IBS™G01 00852G01 008522020-06-11
03760225710975NEOFUSEG01 00862G01 008622020-06-11
03760225711002NEOFUSEG01 00891G01 008912020-06-11
03760225713129IBS™G01 00411G01 004112020-06-11
03760225714263IBS™G01 00421G01 004212020-06-11
03760225717004NEOFUSEP02 00081P02 000812019-07-17
03760225717011NEOFUSEP02 00071P02 000712019-07-17
03760225717110NEOFUSEP02 00171P02 001712019-07-17
03760225717172NEOFUSEP02 00011P02 000112019-07-17
03760225717189NEOFUSEP02 00021P02 000212019-07-17
03760225717219NEOFUSEP02 00051P02 000512019-07-17
03701337606800NEOFUSEP02 00301P02 003012022-05-10
03760225713167IBS™G01 01271G01 012712022-05-09
03760225713174IBS™G01 01261G01 012612022-05-09
03760225713181IBS™G01 01251G01 012512022-05-09
03760225714287IBS™G01 01291G01 012912022-05-09
03760225714294IBS™G01 01301G01 013012022-05-09
03760225714300IBS™G01 01311G01 013112022-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840096408690Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408706Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408713Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408720Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408737Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408744Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408751Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408768Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408775Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408782Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408799Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408805Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408812Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408829Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408836Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408843Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408850Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408867Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408874Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408881Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408898Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408904Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408911Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408928Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408935Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408942Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408959Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408966Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408973Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408980Viant Medical, LLCVIANT MEDICALHTO2020-09-03