The following data is part of a premarket notification filed by Cryptych Pty Ltd with the FDA for Precision Screw.
| Device ID | K160385 |
| 510k Number | K160385 |
| Device Name: | Precision Screw |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | CRYPTYCH PTY LTD SUITE 106, 275 ALFRED STREET North Sydney, AU 2060 |
| Contact | Greg Roger |
| Correspondent | Dave Thomson STRATEGIC MEDICAL COMPLIANCE 42 FOUNTAINS RD Narara, AU 2250 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-11 |
| Decision Date | 2016-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09351290000081 | K160385 | 000 |
| 09351290000074 | K160385 | 000 |