The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Normed Bone Transport.
| Device ID | K990140 |
| 510k Number | K990140 |
| Device Name: | NORMED BONE TRANSPORT |
| Classification | Plate, Bone |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Contact | J. Edward Carchidi |
| Correspondent | J. Edward Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-03-25 |