The following data is part of a premarket notification filed by Smith & Nephew, Inc., Orthopaedic Div. with the FDA for Compass Universal Hinge.
| Device ID | K970713 |
| 510k Number | K970713 |
| Device Name: | COMPASS UNIVERSAL HINGE |
| Classification | Pin, Fixation, Threaded |
| Applicant | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Jo Ann Kuhne |
| Correspondent | Jo Ann Kuhne SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-27 |
| Decision Date | 1997-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556011744 | K970713 | 000 |