The following data is part of a premarket notification filed by Maxx Orthopedics, Inc. with the FDA for Libertas Acetabular Hooded Liner.
| Device ID | K183365 |
| 510k Number | K183365 |
| Device Name: | Libertas Acetabular Hooded Liner |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Maxx Orthopedics, Inc. 2460 General Armistead Avenue, Suite 100 Norristown, PA 19403 |
| Contact | Priscilla Herpai |
| Correspondent | Priscilla Herpai Maxx Orthopedics, Inc. 2460 General Armistead Avenue, Suite 100 Norristown, PA 19403 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-04 |
| Decision Date | 2019-02-22 |