The following data is part of a premarket notification filed by Orthosoft, Inc. (d/b/a Zimmer Cas) with the FDA for Efficient Care 3d Planning.
| Device ID | K183544 |
| 510k Number | K183544 |
| Device Name: | Efficient Care 3D Planning |
| Classification | System, Image Processing, Radiological |
| Applicant | Orthosoft, Inc. (d/b/a Zimmer CAS) 75 Queen St., Suite 3300 Montreal, CA H3c 2n6 |
| Contact | Paul Hardy |
| Correspondent | Paul Hardy Orthosoft, Inc. (d/b/a Zimmer CAS) 75 Queen St., Suite 3300 Montreal, CA H3c 2n6 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-20 |
| Decision Date | 2019-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868397547 | K183544 | 000 |