The following data is part of a premarket notification filed by Smith & Nephew, Inc., Orthopaedic Div. with the FDA for Taylor Spatial Frame External Fixation System.
| Device ID | K970748 |
| 510k Number | K970748 |
| Device Name: | TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Joanne Kuhne |
| Correspondent | Joanne Kuhne SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-03 |
| Decision Date | 1997-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556126943 | K970748 | 000 |
| 00885556126936 | K970748 | 000 |
| 00885556126929 | K970748 | 000 |
| 00885556126912 | K970748 | 000 |
| 00885556043295 | K970748 | 000 |
| 00885556042939 | K970748 | 000 |
| 03596010484499 | K970748 | 000 |
| 03596010484482 | K970748 | 000 |