The following data is part of a premarket notification filed by Remex Medical Corporation with the FDA for Anatase Spine Surgery Navigation System, Model Number: Sns-spine2-s And Sns-spine2-v.
| Device ID | K220348 |
| 510k Number | K220348 |
| Device Name: | Anatase Spine Surgery Navigation System, Model Number: SNS-Spine2-S And SNS-spine2-V |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Remex Medical Corporation 4F., No. 9, Jingke Road, Nantun Dist. Taichung, TW 408224 |
| Contact | Chuang Shih-Chang |
| Correspondent | Sandy Liu Jin Services Co. 9F-1, No13, Lane41, Zhangrong Rd, Sec. 5, North District Tainan City, TW 70447 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-07 |
| Decision Date | 2022-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719876737106 | K220348 | 000 |
| 04719876737090 | K220348 | 000 |
| 04719876737083 | K220348 | 000 |
| 04719876732347 | K220348 | 000 |
| 04719876732330 | K220348 | 000 |
| 04719876732323 | K220348 | 000 |
| 04719876737250 | K220348 | 000 |
| 04719876737120 | K220348 | 000 |
| 04719876737281 | K220348 | 000 |