The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Howmedica Monotube T-connector.
| Device ID | K936124 |
| 510k Number | K936124 |
| Device Name: | HOWMEDICA MONOTUBE T-CONNECTOR |
| Classification | Component, Traction, Invasive |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-23 |
| Decision Date | 1994-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327087819 | K936124 | 000 |
| 07613327087772 | K936124 | 000 |
| 07613327087765 | K936124 | 000 |