OPTILINK 42231250

GUDID H679422312500

5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/50MM

SYNTHES (U.S.A.) LP

Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

Primary Device ID	H679422312500
NIH Device Record Key	c9927c33-bc65-4878-8a6d-aa5498d0d80b
Commercial Distribution Status	In Commercial Distribution
Brand Name	OPTILINK
Version Model Number	42.231.250
Catalog Number	42231250
Company DUNS	832637081
Company Name	SYNTHES (U.S.A.) LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982259479 [Primary]
HIBCC	H679422312500 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162124

FDA Product Code

JDQ	Cerclage, fixation