Vantage 351-00-28

GUDID 10885862546081

FCT CPLD CT BLCK SZ 3R

Exactech, Inc.

Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable

• Primary Device ID: 10885862546081
• NIH Device Record Key: 912a7680-2501-4610-b53d-d27b26a2ebf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vantage
• Version Model Number: 351-00-28
• Catalog Number: 351-00-28
• 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: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862546081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183343

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

[10885862546081]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18

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