The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Small External Fixator (s/e/f/).
| Device ID | K951357 |
| 510k Number | K951357 |
| Device Name: | EBI SMALL EXTERNAL FIXATOR (S/E/F/) |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Contact | Dan L Page |
| Correspondent | Dan L Page ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-24 |
| Decision Date | 1995-06-21 |