| Primary Device ID | 00850044114368 | 
| NIH Device Record Key | e3a475f3-36cd-4212-8795-2d96576dd79d | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Accu-Joint | 
| Version Model Number | AJPT-11 | 
| Catalog Number | AJPT-11 | 
| Company DUNS | 045694474 | 
| Company Name | Accufix Surgical, Inc. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 00850044114368 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00850044114368]
Moist Heat or Steam Sterilization
[00850044114368]
Moist Heat or Steam Sterilization
[00850044114368]
Moist Heat or Steam Sterilization
[00850044114368]
Moist Heat or Steam Sterilization
[00850044114368]
Moist Heat or Steam Sterilization
[00850044114368]
Moist Heat or Steam Sterilization
[00850044114368]
Moist Heat or Steam Sterilization
[00850044114368]
Moist Heat or Steam Sterilization
[00850044114368]
Moist Heat or Steam Sterilization
[00850044114368]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-11-14 | 
| Device Publish Date | 2022-11-04 | 
| 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 | 
| 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 |