ChronOS 71005197S

GUDID H67971005197S0

CHRONOS(TM) BETA-TCP WEDGE 14 DEG/RECTANGULAR-STERILE

Synthes GmbH

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: H67971005197S0
• NIH Device Record Key: 346912e4-4e13-4c12-a083-9e40a8dc64dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ChronOS
• Version Model Number: 710.051.97S
• Catalog Number: 71005197S
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982255716 [Primary]
HIBCC	H67971005197S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043045

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-05-02
• Device Publish Date: 2015-09-14

On-Brand Devices [ChronOS]

• H9810780120099S0: CHRONOS BETA-TCP STRIP MX TWO STRIPS 47MMX18MMX3MM-STER
• H9810780111199S0: CHRONOS(TM) BETA-TCP STRIP 100MM X 25MM X 6MM-STERILE
• H9810780111099S0: CHRONOS(TM) BETA-TCP STRIP 50MM X 25MM X 6MM-STERILE
• H9810780110199S0: CHRONOS(TM) BETA-TCP STRIP 100MM X 25MM X 3MM-STERILE
• H9810780110099S0: CHRONOS(TM) BETA-TCP STRIP 50MM X 25MM X 3MM-STERILE
• H98171093899S0: CHRONOS(TM) SMALL CYLINDER-CP SIZE 12-STERILE
• H98171093799S0: CHRONOS(TM) SMALL CYLINDER-CP SIZE 11-STERILE
• H98171093699S0: CHRONOS(TM) SMALL CYLINDER-CP SIZE 10-STERILE
• H98171093599S0: CHRONOS(TM) SMALL CYLINDER-CP SIZE 9-STERILE
• H98171093499S0: CHRONOS(TM) SMALL CYLINDER-CP SIZE 8-STERILE
• H98171093399S0: CHRONOS(TM) SMALL CYLINDER-CP SIZE 7-STERILE
• H98171093299S0: CHRONOS(TM) SMALL CYLINDER-CP SIZE 6-STERILE
• H98171093199S0: CHRONOS(TM) SMALL CYLINDER-CP SIZE 5-STERILE
• H98171092899S0: CHRONOS(TM) SMALL CYLINDER-L SIZE 12-STERILE
• H98171092799S0: CHRONOS(TM) SMALL CYLINDER-L SIZE 11-STERILE
• H98171092699S0: CHRONOS(TM) SMALL CYLINDER-L SIZE 10-STERILE
• H98171092599S0: CHRONOS(TM) SMALL CYLINDER-L SIZE 9-STERILE
• H98171092499S0: CHRONOS(TM) SMALL CYLINDER-L SIZE 8-STERILE
• H98171092399S0: CHRONOS(TM) SMALL CYLINDER-L SIZE 7-STERILE
• H98171092299S0: CHRONOS(TM) SMALL CYLINDER-L SIZE 6-STERILE
• H98171092199S0: CHRONOS(TM) SMALL CYLINDER-L SIZE 5-STERILE
• H98171003999S0: SYNTHETIC VERTEFILL(TM) CHRONOS(TM) 17MM DIA-STERILE
• H98171003899S0: SYNTHETIC VERTEFILL(TM) CHRONOS(TM) 15MM DIA-STERILE
• H98171002799S0: CHRONOS(TM) GRANULES-LARGE 2.8-5.6MM/20CC-STERILE
• H98171002699S0: CHRONOS(TM) GRANULES-LARGE 2.8-5.6MM/10CC-STERILE
• H98171002599S0: CHRONOS(TM) GRANULES-LARGE 2.8-5.6MM/5CC-STERILE
• H98171002199S0: CHRONOS(TM) GRANULES-MEDIUM 1.4-2.8MM/20CC-STERILE
• H98171001999S0: CHRONOS(TM) GRANULES-MEDIUM 1.4-2.8MM/10CC-STERILE
• H98171001499S0: CHRONOS(TM) GRANULES-MEDIUM 1.4-2.8MM/5CC-STERILE
• H98171000299S0: CHRONOS(TM) GRANULES-SMALL 0.7-1.4MM/1CC-STERILE
• H67971006397S0: CHRONOS(TM) BETA-TCP WEDGE 13 DEG/SEMI-CIRCULAR-STERILE
• H67971006097S0: CHRONOS(TM) BETA-TCP WEDGE 10 DEG/SEMI-CIRCULAR-STERILE
• H67971005797S0: CHRONOS(TM) BETA-TCP WEDGE 7 DEG/SEMI-CIRCULAR-STERILE
• H67971005397S0: CHRONOS(TM) BETA-TCP WEDGE 22 DEG/RECTANGULAR-STERILE
• H67971005297S0: CHRONOS(TM) BETA-TCP WEDGE 18 DEG/RECTANGULAR-STERILE
• H67971005197S0: CHRONOS(TM) BETA-TCP WEDGE 14 DEG/RECTANGULAR-STERILE
• H67971005097S0: CHRONOS(TM) BETA-TCP WEDGE 10 DEG/RECTANGULAR-STERILE
• H67971004797S0: CHRONOS(TM) BETA-TCP BLOCK 20MM X 20MM X 10MM-STERILE
• H67971004597S0: CHRONOS(TM) BETA-TCP BLOCK 12.5MM X 12.5MM X 10MM-STERILE
• H67971002797S0: CHRONOS(TM) GRANULES-LARGE 2.8-5.6MM/20CC-STERILE
• H67971002697S0: CHRONOS(TM) GRANULES-LARGE 2.8-5.6MM/10CC-STERILE
• H67971002597S0: CHRONOS(TM) GRANULES-LARGE 2.8-5.6MM/5CC-STERILE
• H67971002197S0: CHRONOS(TM) GRANULES-MEDIUM 1.4-2.8MM/20CC-STERILE
• H67971001997S0: CHRONOS(TM) GRANULES-MEDIUM 1.4-2.8MM/10CC-STERILE
• H67971001497S0: CHRONOS(TM) GRANULES-MEDIUM 1.4-2.8MM/5CC-STERILE