The following data is part of a premarket notification filed by Christopher D. Endara with the FDA for External Fixator System.
| Device ID | K122208 |
| 510k Number | K122208 |
| Device Name: | EXTERNAL FIXATOR SYSTEM |
| Classification | System, External Fixator (with Metallic Invasive Components) |
| Applicant | CHRISTOPHER D. ENDARA 11767 S. DIXIE HWY #313 Miami, FL 33156 |
| Contact | Christopher Endara |
| Correspondent | Christopher Endara CHRISTOPHER D. ENDARA 11767 S. DIXIE HWY #313 Miami, FL 33156 |
| Product Code | NDK |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2012-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888867241909 | K122208 | 000 |
| 00888867241220 | K122208 | 000 |
| 00888867241213 | K122208 | 000 |
| 00888867241206 | K122208 | 000 |
| 00888867241190 | K122208 | 000 |
| 00888867241183 | K122208 | 000 |
| 00888867241176 | K122208 | 000 |
| 00888867241169 | K122208 | 000 |
| 00888867241121 | K122208 | 000 |
| 00888867241046 | K122208 | 000 |
| 00888867241237 | K122208 | 000 |
| 00888867241244 | K122208 | 000 |
| 00888867241275 | K122208 | 000 |
| 00888867241268 | K122208 | 000 |
| 00888867241152 | K122208 | 000 |
| 00888867241145 | K122208 | 000 |
| 00888867241138 | K122208 | 000 |
| 00888867241114 | K122208 | 000 |
| 00888867241107 | K122208 | 000 |
| 10888867241401 | K122208 | 000 |
| 00888867329126 | K122208 | 000 |
| 00888867241039 | K122208 | 000 |