The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Monotube Carbon Tube.
| Device ID | K963614 |
| 510k Number | K963614 |
| Device Name: | MONOTUBE CARBON TUBE |
| Classification | Component, Traction, Invasive |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | John Dichiara |
| Correspondent | John Dichiara HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-10 |
| Decision Date | 1996-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327079067 | K963614 | 000 |
| 07613327078930 | K963614 | 000 |
| 07613327078947 | K963614 | 000 |
| 07613327078954 | K963614 | 000 |
| 07613327078961 | K963614 | 000 |
| 07613327078978 | K963614 | 000 |
| 07613327078985 | K963614 | 000 |
| 07613327078992 | K963614 | 000 |
| 07613327079005 | K963614 | 000 |
| 07613327079012 | K963614 | 000 |
| 07613327079029 | K963614 | 000 |
| 07613327079036 | K963614 | 000 |
| 07613327079043 | K963614 | 000 |
| 07613327079050 | K963614 | 000 |
| 07613327078923 | K963614 | 000 |