The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System.
| Device ID | K101939 |
| 510k Number | K101939 |
| Device Name: | OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | MERETE MEDICAL GMBH 49 PURCHASE STREET Rye, NY 10580 |
| Contact | Donna Coleman |
| Correspondent | Donna Coleman MERETE MEDICAL GMBH 49 PURCHASE STREET Rye, NY 10580 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-12 |
| Decision Date | 2010-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266078810 | K101939 | 000 |
| 04048266078797 | K101939 | 000 |
| 04048266078827 | K101939 | 000 |
| 04048266078841 | K101939 | 000 |
| 04048266078858 | K101939 | 000 |
| 04048266078872 | K101939 | 000 |
| 04048266078889 | K101939 | 000 |
| 04048266078896 | K101939 | 000 |
| 04048266078902 | K101939 | 000 |
| 04048266078919 | K101939 | 000 |
| 04048266078926 | K101939 | 000 |
| 04048266078933 | K101939 | 000 |
| 04048266078940 | K101939 | 000 |
| 04048266078957 | K101939 | 000 |
| 04048266078964 | K101939 | 000 |
| 04048266078971 | K101939 | 000 |
| 04048266078735 | K101939 | 000 |
| 04048266078780 | K101939 | 000 |