Xcaliber Bone Screws 99-911560

GUDID 18032568863390

XCALIBER BONE SCREW STERILE L150/60MM THREAD D6.0-5.6MM

ORTHOFIX SRL

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID18032568863390
NIH Device Record Key63cb587b-b0a7-4b72-91b6-f929ea987b71
Commercial Distribution StatusIn Commercial Distribution
Brand NameXcaliber Bone Screws
Version Model Number1
Catalog Number99-911560
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exemptfalse
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 Numbertrue
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+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length150 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568863390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-01

Devices Manufactured by ORTHOFIX SRL

18052469476468 - ORTHOFIX2024-07-15 SIZING GUIDE
18052469476475 - ORTHOFIX2024-07-15 TARGETING HANDLE
18052469476482 - ORTHOFIX2024-07-15 TARGETING HANDLE - SHORT
18052469476499 - ORTHOFIX2024-07-15 ENTRY REAMER D12MM
18052469476505 - ORTHOFIX2024-07-15 ENTRY REAMER D13MM
18052469476512 - ORTHOFIX2024-07-15 FITBONE KIRSCHNER WIRE L280MM D3MM PACK OF 2 STERILE
18052469476529 - ORTHOFIX2024-07-15 SHORT SCREWDRIVER RETENTION ROD
18052469476536 - ORTHOFIX2024-07-15 LONG SCREWDRIVER RETENTION ROD

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