The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Nexa Orthopedics Total Shoulder System.
| Device ID | K071147 |
| 510k Number | K071147 |
| Device Name: | NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | NEXA ORTHOPEDICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane NEXA ORTHOPEDICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-24 |
| Decision Date | 2007-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832004386 | K071147 | 000 |
| 00846832004065 | K071147 | 000 |
| 00846832004089 | K071147 | 000 |
| 00846832004102 | K071147 | 000 |
| 00846832004126 | K071147 | 000 |
| 00846832004140 | K071147 | 000 |
| 00846832004164 | K071147 | 000 |
| 00846832004188 | K071147 | 000 |
| 00846832004201 | K071147 | 000 |
| 00846832004225 | K071147 | 000 |
| 00846832004249 | K071147 | 000 |
| 00846832004263 | K071147 | 000 |
| 00846832004287 | K071147 | 000 |
| 00846832004300 | K071147 | 000 |
| 00846832004324 | K071147 | 000 |
| 00846832004348 | K071147 | 000 |
| 00846832004362 | K071147 | 000 |
| 00846832004041 | K071147 | 000 |