The following data is part of a premarket notification filed by Joimax Gmbh with the FDA for Joimax Intracs System.
| Device ID | K192663 |
| 510k Number | K192663 |
| Device Name: | Joimax Intracs System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | joimax GmbH Amalienbadstr. 41, RaumFabrik 61 Karlsruhe, DE 76227 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik joimax GmbH Amalienbadstr. 41, RaumFabrik 61 Karlsruhe, DE 76227 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-25 |
| Decision Date | 2020-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250337118220 | K192663 | 000 |
| 04250337118039 | K192663 | 000 |
| 04250337118046 | K192663 | 000 |
| 04250337116530 | K192663 | 000 |
| 04250337116547 | K192663 | 000 |
| 04250337116554 | K192663 | 000 |
| 04250337116561 | K192663 | 000 |
| 04250337116585 | K192663 | 000 |
| 04250337116592 | K192663 | 000 |
| 04250337116608 | K192663 | 000 |
| 04250337116615 | K192663 | 000 |
| 04250337116622 | K192663 | 000 |
| 04250337116646 | K192663 | 000 |
| 04250337117667 | K192663 | 000 |
| 04250337117995 | K192663 | 000 |
| 04250337118008 | K192663 | 000 |
| 04250337118015 | K192663 | 000 |
| 04250337118213 | K192663 | 000 |
| 04250337118022 | K192663 | 000 |