The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Procotyl L-o Acetabular System.
| Device ID | K142119 |
| 510k Number | K142119 |
| Device Name: | PROCOTYL L-O ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Contact | Byron Ledbetter |
| Correspondent | Byron Ledbetter MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2015-02-27 |
| Summary: | summary |