Accu-Joint AJMI-14-20-2

GUDID 00850044114900

Accu-Joint Hemi Implant - Metatarsal 14mm-2

Accufix Surgical, Inc.

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: 00850044114900
• NIH Device Record Key: fc8f0431-979f-41a3-91d4-4653d808de46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Joint
• Version Model Number: AJMI-14-20-2
• Catalog Number: AJMI-14-20-2
• 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	00850044114900 [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

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

[00850044114900]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-19
• Device Publish Date: 2023-09-11

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