The following data is part of a premarket notification filed by Orthosoft D/b/a Zimmer Cas with the FDA for One Planner Hip.
| Device ID | K210653 |
| 510k Number | K210653 |
| Device Name: | ONE Planner Hip |
| Classification | System, Image Processing, Radiological |
| Applicant | Orthosoft D/b/a Zimmer CAS 75 Queen Street, Suite 3300 Montreal, CA H3c 2n6 |
| Contact | Paul Hardy |
| Correspondent | Paul Hardy Orthosoft D/b/a Zimmer CAS 75 Queen Street, Suite 3300 Montreal, CA H3c 2n6 |
| Product Code | LLZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | PBI |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-04 |
| Decision Date | 2021-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868523106 | K210653 | 000 |