The following data is part of a premarket notification filed by Ctl Medical Corporation with the FDA for Universal Pilot Guidance Instrument System.
| Device ID | K213491 |
| 510k Number | K213491 |
| Device Name: | Universal Pilot Guidance Instrument System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | CTL Medical Corporation 4550 Excel Pkwy Ste 300 Addison, TX 75001 |
| Contact | Sean Suh |
| Correspondent | Dhaval Saraiya Omni Strategic Solutions, LLC 700 Pennsylvania Ave SE 2nd Floor Washington, DC 20003 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-01 |
| Decision Date | 2022-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841732165243 | K213491 | 000 |
| 00841732165250 | K213491 | 000 |
| 00841732166776 | K213491 | 000 |
| 00841732166769 | K213491 | 000 |
| 00841732166639 | K213491 | 000 |
| 00841732166622 | K213491 | 000 |
| 00841732166615 | K213491 | 000 |