The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Copal Exchange G Hip Spacer.
| Device ID | K220492 |
| 510k Number | K220492 |
| Device Name: | COPAL Exchange G Hip Spacer |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | Heraeus Medical GmbH Philipp-Reis-Str. 8/13 Wehrheim, DE 61273 |
| Contact | Heike Gustke |
| Correspondent | Heike Gustke Heraeus Medical GmbH Philipp-Reis-Str. 8/13 Wehrheim, DE 61273 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2022-02-22 |
| Decision Date | 2022-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102139220 | K220492 | 000 |
| 04260102139190 | K220492 | 000 |