Accu-Joint AJPI-9-12

GUDID 00850044114245

Accu-Joint Hemi Implant - Phalangeal 9mm

Accufix Surgical, Inc.

Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis

• Primary Device ID: 00850044114245
• NIH Device Record Key: cc0655f4-9755-484f-a677-67f7120d0f7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Joint
• Version Model Number: AJPI-9-12
• Catalog Number: AJPI-9-12
• Company DUNS: 045694474
• Company Name: Accufix Surgical, 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850044114245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200951

FDA Product Code

• KWD: Prosthesis, Toe, Hemi-, Phalangeal

Sterilization

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

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

[00850044114245]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-28

On-Brand Devices [Accu-Joint]

• 00850044114856: K-Wire Dispenser 0.9mm - 10mmD x 120mmL 304SS
• 00850044114849: 4.0mm Accu-Joint Hemi Implant Tap
• 00850044114832: Reamer Tool Phalanx 9mm
• 00850044114825: Reamer Tool Phalanx 8mm
• 00850044114818: Reamer Tool Phalanx 19mm
• 00850044114801: Reamer Tool Phalanx 17mm
• 00850044114795: Reamer Tool Phalanx 16mm
• 00850044114788: Reamer Tool Phalanx 15mm
• 00850044114771: Reamer Tool Phalanx 13mm
• 00850044114764: Reamer Tool Phalanx 11mm
• 00850044114757: Reamer Tool Phalanx 10mm
• 00850044114740: Reamer Tool Metatarsal 9mm
• 00850044114733: Reamer Tool Metatarsal 20mm
• 00850044114726: Reamer Tool Metatarsal 18mm
• 00850044114719: Reamer Tool Metatarsal 17mm
• 00850044114702: Reamer Tool Metatarsal 16mm
• 00850044114696: Reamer Tool Metatarsal 14mm
• 00850044114689: Reamer Tool Metatarsal 12mm
• 00850044114672: Reamer Tool Metatarsal 11mm
• 00850044114665: Reamer Tool Metatarsal 10mm
• 00850044114658: Operating Room Accujoint Tray/Lid
• 00850044114641: K-Wire Dispenser 1.4mm - 10mmD x 120mmL 304SS
• 00850044114634: K-Wire 100mm L x 1.4mm OD
• 00850044114627: K-Wire 100mm L x 0.9mm OD
• 00850044114252: Accu-Joint Supplemental Caddy
• 00850044114245: Accu-Joint Hemi Implant - Phalangeal 9mm
• 00850044114238: Accu-Joint Hemi Implant - Phalangeal 8mm
• 00850044114221: Accu-Joint Hemi Implant - Phalangeal 19mm
• 00850044114214: Accu-Joint Hemi Implant - Phalangeal 17mm
• 00850044114207: Accu-Joint Hemi Implant - Phalangeal 16mm
• 00850044114191: Accu-Joint Hemi Implant - Phalangeal 15mm
• 00850044114184: Accu-Joint Hemi Implant - Phalangeal 13mm
• 00850044114177: Accu-Joint Hemi Implant - Phalangeal 11mm
• 00850044114160: Accu-Joint Hemi Implant - Phalangeal 10mm
• 00850044114153: Accu-Joint Hemi Implant - Metatarsal 9mm
• 00850044114146: Accu-Joint Hemi Implant - Metatarsal 20mm
• 00850044114139: Accu-Joint Hemi Implant - Metatarsal 18mm
• 00850044114122: Accu-Joint Hemi Implant - Metatarsal 17mm
• 00850044114115: Accu-Joint Hemi Implant - Metatarsal 16mm
• 00850044114108: Accu-Joint Hemi Implant - Metatarsal 14mm
• 00850044114092: Accu-Joint Hemi Implant - Metatarsal 12mm
• 00850044114085: Accu-Joint Hemi Implant - Metatarsal 11mm
• 00850044114078: Accu-Joint Hemi Implant - Metatarsal 10mm
• 00850044114054: ACFX2021-1 Target Tray
• 00850044114047: Drill Bit 1.70mmX80mm, w/1.00 Cannulation, 15mm depth, AO
• 00850044114030: Drill Bit 1.70mmX80mm, w/1.00 Cannulation, 10mm depth, AO
• 00850044114023: Drill Bit 2.70mmX80mm, w/1.50 Cannulation, 15mm depth, AO
• 00850044114016: Drill Bit 2.70mmX80mm, w/1.50 Cannulation, 20mm depth, AO
• 00850044114009: Driver, T6 Torx X15TN SS
• 00850044114429: Accu-Joint Trial - Phalangeal 9mm