The following data is part of a premarket notification filed by Field Orthopaedics Pty. Ltd. with the FDA for Field Orthopaedics Micro Screw System.
| Device ID | K180348 |
| 510k Number | K180348 |
| Device Name: | Field Orthopaedics Micro Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | Field Orthopaedics Pty. Ltd. 375 Wickham Terrace Brisbane, AU 4000 |
| Contact | Christopher Jeffery |
| Correspondent | Robert A Poggie BioVera Inc. 65 Promenade Saint Louis Notre-dame-del-l'ile-perrot, CA J7v 7p2 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-08 |
| Decision Date | 2018-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09353903008484 | K180348 | 000 |
| 09353903004264 | K180348 | 000 |
| 09353903004257 | K180348 | 000 |
| 09353903004240 | K180348 | 000 |
| 09353903004233 | K180348 | 000 |
| 09353903004226 | K180348 | 000 |
| 09353903004219 | K180348 | 000 |
| 09353903004202 | K180348 | 000 |
| 09353903000365 | K180348 | 000 |
| 09353903000358 | K180348 | 000 |
| 09353903000341 | K180348 | 000 |
| 09353903000334 | K180348 | 000 |
| 09353903000327 | K180348 | 000 |
| 09353903000310 | K180348 | 000 |
| 09353903000440 | K180348 | 000 |
| 09353903000457 | K180348 | 000 |
| 09353903001782 | K180348 | 000 |
| 09353903002062 | K180348 | 000 |
| 09353903002055 | K180348 | 000 |
| 09353903002048 | K180348 | 000 |
| 09353903002031 | K180348 | 000 |
| 09353903002024 | K180348 | 000 |
| 09353903000426 | K180348 | 000 |
| 09353903000419 | K180348 | 000 |
| 09353903000402 | K180348 | 000 |
| 09353903000396 | K180348 | 000 |
| 09353903000389 | K180348 | 000 |
| 09353903000372 | K180348 | 000 |
| 09353903000303 | K180348 | 000 |
| 09353903000228 | K180348 | 000 |