The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi X Fix Dynafix Mini External Fixation System.
| Device ID | K970290 |
| 510k Number | K970290 |
| Device Name: | EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | EBI, L.P. 6 UPPER POND RD. Parsippany, NJ 07054 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta EBI, L.P. 6 UPPER POND RD. Parsippany, NJ 07054 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-24 |
| Decision Date | 1997-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868358203 | K970290 | 000 |
| 00887868084157 | K970290 | 000 |
| 00887868084164 | K970290 | 000 |
| 00887868084171 | K970290 | 000 |
| 00887868084188 | K970290 | 000 |
| 00887868084195 | K970290 | 000 |
| 00887868084201 | K970290 | 000 |
| 00887868084218 | K970290 | 000 |
| 00887868084225 | K970290 | 000 |
| 00887868084232 | K970290 | 000 |
| 00887868084249 | K970290 | 000 |
| 00887868358128 | K970290 | 000 |
| 00887868358135 | K970290 | 000 |
| 00887868358142 | K970290 | 000 |
| 00887868358173 | K970290 | 000 |
| 00887868084140 | K970290 | 000 |