Vantage 350-02-01

GUDID 10885862276735

Exactech, Inc.

Coated ankle talus prosthesis

• Primary Device ID: 10885862276735
• NIH Device Record Key: e7437e6b-09b8-4c6a-9181-cbddd64a83d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vantage
• Version Model Number: 350-02-01
• Catalog Number: 350-02-01
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• 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: false
• Serial Number: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862276735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152217

FDA Product Code

• HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-07-17

On-Brand Devices [Vantage]

• 10885862546326: 350-04-05
• 10885862546319: 350-04-04
• 10885862546302: 350-04-03
• 10885862546296: 350-04-02
• 10885862546289: 350-04-01
• 10885862546272: 350-03-05
• 10885862546265: 350-03-04
• 10885862546258: 350-03-03
• 10885862546241: 350-03-02
• 10885862546234: 350-03-01
• 10885862585219: SK-032634
• 10885862603135: 351-00-06
• 10885862607317: SPI-041941
• 10885862605733: SPI-040950
• 10885862594846: SPI-038190
• 10885862594839: SPI-038199
• 10885862594822: SPI-038191
• 10885862594815: SPI-038192
• 10885862301536: 350-02-05
• 10885862301529: 350-01-05
• 10885862276766: 350-02-04
• 10885862276759: 350-02-03
• 10885862276742: 350-02-02
• 10885862276735: 350-02-01
• 10885862276728: 350-01-04
• 10885862276711: 350-01-03
• 10885862276704: 350-01-02
• 10885862276698: 350-01-01
• 10885862595249: SPI-038414
• 10885862595232: SPI-038413
• 10885862588807: ANKLE DISTRACTOR CONST
• 10885862566539: VANTAGE CORNER CHISEL
• 10885862566164: TIBIAL ALIGNMENT GUIDE ASSEMBLY
• 10885862565655: MB ANGEL WING
• 10885862563415: LP TALAR IMPACTOR INSERT
• 10885862563408: LP TALAR IMPACTOR FRAME
• 10885862559050: FCT CORING DRILL
• 10885862555878: PIN, FLUTED
• 10885862541987: THREADED OLIVE POUCH 2PK
• 10885862541970: THREADED PIN POUCH 2PK
• 10885862541963: TALAR TRIAL SCREW POUCH
• 10885862541956: OLIVE PIN POUCH
• 10885862541727: ANKLE TIBIAL INSERTER
• 10885862536266: ANGEL WING
• 10885862535115: LONG TALAR SCREW POUCH 2PK
• 10885862534378: X-RAY TEMPLATE
• 10885862534361: ANKLE XRAY TEMP - TIBIA
• 10885862533609: LONG TALAR TRIAL SCREW
• 10885862533593: THREADED OLIVE PIN
• 10885862532282: VANTAGE TBL RADEL IMPCTR