| Primary Device ID | 00860005968800 |
| NIH Device Record Key | a29e99f9-8c8f-4346-92c6-ae27d99a5729 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIS Precision Chevron Bunion System |
| Version Model Number | RI-2427-C |
| Company DUNS | 113596350 |
| Company Name | Relja Innovations LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 210-338-0580 |
| dave@reljainnovations.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005968800 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-02-19 |
| Device Publish Date | 2022-12-21 |
| 00860005968824 - RELJA Innovations Nitinol Staple Kit 15mmx12mm | 2025-09-29 RELJA Innovations Nitinol Staple Kit 15mmx12mm |
| 00860005968831 - RELJA Innovations Nitinol Staple Kit 18x18 | 2025-09-29 RELJA Innovations Nitinol Staple Kit 18x18 |
| 00860005968800 - MIS Precision Chevron Bunion System | 2024-02-19The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel. |
| 00860005968800 - MIS Precision Chevron Bunion System | 2024-02-19 The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subseq |
| 00860005968817 - RELJA Reduction Clamp (Left and Right) | 2024-01-11 The Relja Innovations Reduction Clamp is a manual surgical instrument intended to position and compress the metatarsal joints du |