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 |