SOLE MEDIAL COLUMN FUSION PLATE 99-841428

GUDID 18053340346948

SS VA LOCKING SCREW L28MM D4MM STERILE

ORTHOFIX SRL

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID18053340346948
NIH Device Record Key936c36d4-d1a4-4662-ac45-4ecea9b7e217
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOLE MEDIAL COLUMN FUSION PLATE
Version Model Number1
Catalog Number99-841428
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it

Device Dimensions

Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter
Outer Diameter4 Millimeter
Length28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118053340346948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-11
Device Publish Date2021-06-03

On-Brand Devices [SOLE MEDIAL COLUMN FUSION PLATE]

18053340348652SOLE MCF TRAY COMPLETE EMPTY
18053340348522SS NON-LOCKING SCREW L60MM D4MM
18053340348515SS NON-LOCKING SCREW L55MM D4MM
18053340348508SS NON-LOCKING SCREW L50MM D4MM
18053340348492SS NON-LOCKING SCREW L46MM D4MM
18053340348485SS NON-LOCKING SCREW L42MM D4MM
18053340348478SS NON-LOCKING SCREW L38MM D4MM
18053340348461SS NON-LOCKING SCREW L34MM D4MM
18053340348454SS NON-LOCKING SCREW L30MM D4MM
18053340348447SS NON-LOCKING SCREW L28MM D4MM
18053340348430SS NON-LOCKING SCREW L26MM D4MM
18053340348423SS NON-LOCKING SCREW L24MM D4MM
18053340348416SS NON-LOCKING SCREW L22MM D4MM
18053340348409SS NON-LOCKING SCREW L20MM D4MM
18053340348393SS NON-LOCKING SCREW L18MM D4MM
18053340348386SS NON-LOCKING SCREW L16MM D4MM
18053340348379SS NON-LOCKING SCREW L14MM D4MM
18053340348362SS NON-LOCKING SCREW L12MM D4MM
18053340348355SS NON-LOCKING SCREW L10MM D4MM
18053340348348SS NON-LOCKING SCREW L60MM D5MM
18053340348331SS NON-LOCKING SCREW L55MM D5MM
18053340348324SS NON-LOCKING SCREW L50MM D5MM
18053340348317SS NON-LOCKING SCREW L46MM D5MM
18053340348300SS NON-LOCKING SCREW L42MM D5MM
18053340348294SS NON-LOCKING SCREW L38MM D5MM
18053340348287SS NON-LOCKING SCREW L34MM D5MM
18053340348270SS NON-LOCKING SCREW L30MM D5MM
18053340348263SS NON-LOCKING SCREW L28MM D5MM
18053340348256SS NON-LOCKING SCREW L26MM D5MM
18053340348249SS NON-LOCKING SCREW L24MM D5MM
18053340348232SS NON-LOCKING SCREW L22MM D5MM
18053340348225SS NON-LOCKING SCREW L20MM D5MM
18053340348218SS NON-LOCKING SCREW L18MM D5MM
18053340348201SS NON-LOCKING SCREW L16MM D5MM
18053340348195SS NON-LOCKING SCREW L14MM D5MM
18053340348188SS NON-LOCKING SCREW L12MM D5MM
18053340348171SS NON-LOCKING SCREW L10MM D5MM
18053340348164SS VA LOCKING SCREW L60MM D4MM
18053340348157SS VA LOCKING SCREW L55MM D4MM
18053340348140SS VA LOCKING SCREW L50MM D4MM
18053340348133SS VA LOCKING SCREW L46MM D4MM
18053340348126SS VA LOCKING SCREW L42MM D4MM
18053340348119SS VA LOCKING SCREW L38MM D4MM
18053340348102SS VA LOCKING SCREW L34MM D4MM
18053340348096SS VA LOCKING SCREW L30MM D4MM
18053340348089SS VA LOCKING SCREW L28MM D4MM
18053340348072SS VA LOCKING SCREW L26MM D4MM
18053340348065SS VA LOCKING SCREW L24MM D4MM
18053340348058SS VA LOCKING SCREW L22MM D4MM
18053340348041SS VA LOCKING SCREW L20MM D4MM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.