FDA.reportPublic FDA data

BIOINTRAFIX

Primary DI
10886705013210
Brand
BIOINTRAFIX
Company
Medos International Sàrl
Model
254624
Catalog number
254624
Device description
BIO-INTRAFIX Tapered Screw 7-9mm x 30mm
Published
2015-09-01
Public version status
Update
Distribution status
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
K032167000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032167000BIO-INTRAFIX TIBIAL SCREW AND SHEATHMitek Worldwide2003-10-15HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705013210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670501321010886705013210

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034369983SKYLINE4102901304102901302016-12-31
10705034648194VELYS4516110654516110652026-10-09
10705034648200VELYS4516110644516110642026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04
00856879006281FIBERGRAFT Aeridyan Matrix59000063590000632021-08-04
00856879006298FIBERGRAFT Aeridyan Matrix59000015590000152021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053782783830TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783847TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783915TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783922TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783939TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783946TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783953TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783960TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783977TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784134TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784141TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784158TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784165TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784172TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784189TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784264CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784271CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784288CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784295CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784301CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784318CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784325CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784523CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784530CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784547CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784554CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784561CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784578CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784585CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784592CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19