The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Monotube Tube To Ring Clamp.
| Device ID | K961618 |
| 510k Number | K961618 |
| Device Name: | MONOTUBE TUBE TO RING CLAMP |
| 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 | 1996-04-26 |
| Decision Date | 1996-05-28 |
| Summary: | summary |