The following data is part of a premarket notification filed by Tri-med, Inc. with the FDA for Tbw.
| Device ID | K010545 |
| 510k Number | K010545 |
| Device Name: | TBW |
| Classification | Pin, Fixation, Smooth, Metallic |
| Applicant | TRI-MED, INC. 159 KU'UKAMA ST. Kailua,, HI 96734 |
| Contact | Robert J Medoff |
| Correspondent | Robert J Medoff TRI-MED, INC. 159 KU'UKAMA ST. Kailua,, HI 96734 |
| Product Code | NDL |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-23 |
| Decision Date | 2001-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842188109232 | K010545 | 000 |
| 00842188109096 | K010545 | 000 |
| 00842188109089 | K010545 | 000 |
| 00842188109072 | K010545 | 000 |
| 00842188109065 | K010545 | 000 |
| 00842188109058 | K010545 | 000 |
| 00842188109041 | K010545 | 000 |
| 00842188119859 | K010545 | 000 |
| 00842188123863 | K010545 | 000 |