OPAL SD08803234

GUDID H981SD088032340

OPAL SPACER 10MM X 32MM 14MM HEIGHT-REVOLVE

SYNTHES (U.S.A.) LP

Polymeric spinal interbody fusion cage

• Primary Device ID: H981SD088032340
• NIH Device Record Key: 3434c702-8ab6-4341-ac15-c12581774ad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPAL
• Version Model Number: SD08.803.234
• Catalog Number: SD08803234
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034705347 [Primary]
HIBCC	H981SD088032340 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072791

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

[H981SD088032340]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-14

On-Brand Devices [OPAL]

• H981088032350: OPAL SPACER 10MM X 32MM 15MM HEIGHT-REVOLVE
• H981088032340: OPAL SPACER 10MM X 32MM 14MM HEIGHT-REVOLVE
• H981088032330: OPAL SPACER 10MM X 32MM 13MM HEIGHT-REVOLVE
• H981088032320: OPAL SPACER 10MM X 32MM 12MM HEIGHT-REVOLVE
• H981088032310: OPAL SPACER 10MM X 32MM 11MM HEIGHT-REVOLVE
• H981088032300: OPAL SPACER 9MM X 32MM 10MM HEIGHT-REVOLVE
• H981088032170: OPAL SPACER 10MM X 32MM 17MM HEIGHT
• H981088032160: OPAL SPACER 10MM X 32MM 16MM HEIGHT
• H981088032150: OPAL SPACER 10MM X 32MM 15MM HEIGHT
• H981088032140: OPAL SPACER 10MM X 32MM 14MM HEIGHT
• H981088032130: OPAL SPACER 10MM X 32MM 13MM HEIGHT
• H981088032120: OPAL SPACER 10MM X 32MM 12MM HEIGHT
• H981088032110: OPAL SPACER 10MM X 32MM 11MM HEIGHT
• H981088032100: OPAL SPACER 10MM X 32MM 10MM HEIGHT
• H981088032090: OPAL SPACER 10MM X 32MM 9MM HEIGHT
• H981088032080: OPAL SPACER 10MM X 32MM 8MM HEIGHT
• H981088032070: OPAL SPACER 10MM X 32MM 7MM HEIGHT
• H981088031350: OPAL SPACER 10MM X 28MM 15MM HEIGHT-REVOLVE
• H981088031340: OPAL SPACER 10MM X 28MM 14MM HEIGHT-REVOLVE
• H981088031330: OPAL SPACER 10MM X 28MM 13MM HEIGHT-REVOLVE
• H981088031320: OPAL SPACER 10MM X 28MM 12MM HEIGHT-REVOLVE
• H981088031310: OPAL SPACER 10MM X 28MM 11MM HEIGHT-REVOLVE
• H981088031300: OPAL SPACER 9MM X 28MM 10MM HEIGHT-REVOLVE
• H981088031170: OPAL SPACER 10MM X 28MM 17MM HEIGHT
• H981088031160: OPAL SPACER 10MM X 28MM 16MM HEIGHT
• H981088031150: OPAL SPACER 10MM X 28MM 15MM HEIGHT
• H981088031140: OPAL SPACER 10MM X 28MM 14MM HEIGHT
• H981088031130: OPAL SPACER 10MM X 28MM 13MM HEIGHT
• H981088031120: OPAL SPACER 10MM X 28MM 12MM HEIGHT
• H981088031110: OPAL SPACER 10MM X 28MM 11MM HEIGHT
• H981088031100: OPAL SPACER 10MM X 28MM 10MM HEIGHT
• H981088031090: OPAL SPACER 10MM X 28MM 9MM HEIGHT
• H981088031080: OPAL SPACER 10MM X 28MM 8MM HEIGHT
• H981088031070: OPAL SPACER 10MM X 28MM 7MM HEIGHT
• H981088030550: OPAL SPACER 10MM X 24MM 15MM HEIGHT-REVOLVE
• H981088030530: OPAL SPACER 10MM X 24MM 13MM HEIGHT-REVOLVE
• H981088030520: OPAL SPACER 10MM X 24MM 12MM HEIGHT-REVOLVE
• H981088030510: OPAL SPACER 10MM X 24MM 11MM HEIGHT-REVOLVE
• H981088030500: OPAL SPACER 9MM X 24MM 10MM HEIGHT-REVOLVE
• H981SD088032340: OPAL SPACER 10MM X 32MM 14MM HEIGHT-REVOLVE
• H981SD088032160: OPAL SPACER 10MM X 32MM 16MM HEIGHT
• H981SD088032140: OPAL SPACER 10MM X 32MM 14MM HEIGHT
• H981SD088031340: OPAL SPACER 10MM X 28MM 14MM HEIGHT-REVOLVE
• H981SD088031160: OPAL SPACER 10MM X 28MM 16MM HEIGHT
• H981SD088031140: OPAL SPACER 10MM X 28MM 14MM HEIGHT
• H981SD088030540: OPAL SPACER 10MM X 24MM 14MM HEIGHT-REVOLVE
• 07611819940598: OPAL IMPLANT HOLDER STRAIGHT
• H981608031030: MODULE FOR OPAL SPACERS- REVOLVE 10MM X 24MM
• H981608031020: MODULE FOR OPAL SPACERS- REVOLVE
• H981608031010: MODULE FOR OPAL SPACERS