Accu-Joint AJPI-11-15
GUDID 00850044114177
Accu-Joint Hemi Implant - Phalangeal 11mm
Accufix Surgical, Inc.
Partial metatarsophalangeal joint prosthesis| Primary Device ID | 00850044114177 |
| NIH Device Record Key | b5bb71bc-924e-46ee-bff9-42cda93badd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accu-Joint |
| Version Model Number | AJPI-11-15 |
| Catalog Number | AJPI-11-15 |
| 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 | 00850044114177 [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 |
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
Moist Heat or Steam Sterilization
[00850044114177]
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 |
Trademark Results [Accu-Joint]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCU-JOINT 90138848 not registered Live/Pending |
Accufix Surgical Inc. 2020-08-26 |
 ACCU-JOINT 78271981 not registered Dead/Abandoned |
Howmedica Osteonics Corp. 2003-07-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.