The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Bioball Delta Ceramic Heads, Multicup Pe Inlay Standard.
| Device ID | K141377 |
| 510k Number | K141377 |
| Device Name: | BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MERETE MEDICAL GMBH ALT LANKWITZ 102 Berlin, DE 12247 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis MERETE MEDICAL GMBH ALT LANKWITZ 102 Berlin, DE 12247 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2014-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266025470 | K141377 | 000 |
| 04048266025463 | K141377 | 000 |
| 04048266143549 | K141377 | 000 |
| 04048266143532 | K141377 | 000 |
| 04048266143525 | K141377 | 000 |