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
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
03760225717127NEOFUSEG01 01561G01 015612020-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463925VersiTomic 2-Fluted Cannulated Reamer Ø5.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463932VersiTomic 2-Fluted Cannulated Reamer Ø5.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463949VersiTomic 2-Fluted Cannulated Reamer Ø6.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463956VersiTomic 2-Fluted Cannulated Reamer Ø6.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463963VersiTomic 2-Fluted Cannulated Reamer Ø7.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463970VersiTomic 2-Fluted Cannulated Reamer Ø7.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463987VersiTomic 2-Fluted Cannulated Reamer Ø8.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463994VersiTomic 2-Fluted Cannulated Reamer Ø8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464007VersiTomic 2-Fluted Cannulated Reamer Ø9.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464014VersiTomic 2-Fluted Cannulated Reamer Ø9.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464021VersiTomic 2-Fluted Cannulated Reamer Ø10.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464038VersiTomic 2-Fluted Cannulated Reamer Ø10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464045VersiTomic 2-Fluted Cannulated Reamer Ø11.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464052VersiTomic 2-Fluted Cannulated Reamer Ø12.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464069VersiTomic 2-Fluted Cannulated Reamer Ø13.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
00190376544502InvictusALPHATEC SPINE, INC.HTO2026-07-30
03701089526364AMPLITUDEAMPLITUDE SASHTO2026-07-29
03701089526371AMPLITUDEAMPLITUDE SASHTO2026-07-29
03701089526388AMPLITUDEAMPLITUDE SASHTO2026-07-29
03700569676636Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
03700569676643Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
03700569676650Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
18059015378320Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378337Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378344Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378351Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378399Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
10810128461426Back Drill 4.5 X 7.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-07-22
10810128461440Back Drill 4.5 X 8.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-07-22