FDA.reportPublic FDA data

DuaFit®

Primary DI
03701337603113
Brand
DuaFit®
Company
IN2BONES
Model
A60 SP172 B
Device description
Interphalangeal implants
Published
2019-11-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132912000DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANTIn2bones Sas2014-07-30HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701337603113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701337603113037013376031133701337603113

GMDN Terms#

Term, Definition table
TermDefinition
Proximal interphalangeal joint prosthesis, one-pieceA sterile implantable artificial substitute for the proximal interphalangeal (PIP) joint(s) of the hand (finger) which has been damaged by rheumatoid, degenerative, or traumatic arthritis. It consists of a single flexible across-the-joint component made from either a silicone elastomer or a combination of polypropylene and polyester materials. The flexible across-the-joint component may be covered with a silicone rubber sleeve.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle17degree
Length14Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33472292626contact@in2bones.com

Regulatory Flags#

DUNS number
263616749
Device count
1
Lot or batch
true
Expiration date on label
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

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Primary DI, Brand, Company table
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