The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Cable-ease Plate And Cable System.
| Device ID | K944529 |
| 510k Number | K944529 |
| Device Name: | CABLE-EASE PLATE AND CABLE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Barry J Hassett |
| Correspondent | Barry J Hassett INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1995-02-17 |