The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Copal Exchange G Hip And Knee Spacers.
| Device ID | K191016 |
| 510k Number | K191016 |
| Device Name: | COPAL Exchange G Hip And Knee Spacers |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | Heraeus Medical GmbH Philipp-Reis-Str. 8/13 Werheim, DE 61273 |
| Contact | Ljuba Jitaau |
| Correspondent | Mary Mcnamara-cullinane Alira Health 1 Grant Street Framingham, MA 01702 |
| Product Code | KWY |
| Subsequent Product Code | KWH |
| Subsequent Product Code | KWL |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-04-17 |
| Decision Date | 2019-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102136991 | K191016 | 000 |
| 04260102136724 | K191016 | 000 |
| 04260102136755 | K191016 | 000 |
| 04260102136786 | K191016 | 000 |
| 04260102136816 | K191016 | 000 |
| 04260102136847 | K191016 | 000 |
| 04260102136878 | K191016 | 000 |
| 04260102136885 | K191016 | 000 |
| 04260102136939 | K191016 | 000 |
| 04260102136960 | K191016 | 000 |
| 04260102136694 | K191016 | 000 |