The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Osleobridge Idsf Spacer Conector.
| Device ID | K113303 |
| 510k Number | K113303 |
| Device Name: | OSLEOBRIDGE IDSF SPACER CONECTOR |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin, DE D-12247 |
| Contact | Emmanuel Anapliois |
| Correspondent | Emmanuel Anapliois MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin, DE D-12247 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-09 |
| Decision Date | 2011-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266000804 | K113303 | 000 |
| 04048266000798 | K113303 | 000 |
| 04048266000781 | K113303 | 000 |