The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Intrablock Bioball Hip System (ibs).
| Device ID | K123619 |
| 510k Number | K123619 |
| Device Name: | INTRABLOCK BIOBALL HIP SYSTEM (IBS) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin, DE D-12247 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin, DE D-12247 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-23 |
| Decision Date | 2013-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266025456 | K123619 | 000 |