The following data is part of a premarket notification filed by Smith & Nephew, Inc., Orthopaedic Div. with the FDA for Heidelberg External Fixator.
| Device ID | K970751 |
| 510k Number | K970751 |
| Device Name: | HEIDELBERG EXTERNAL FIXATOR |
| Classification | Pin, Fixation, Threaded |
| Applicant | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Joanne Khune |
| Correspondent | Joanne Khune 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 | 1997-03-03 |
| Decision Date | 1997-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556011089 | K970751 | 000 |
| 03596010439833 | K970751 | 000 |
| 03596010454447 | K970751 | 000 |
| 03596010454454 | K970751 | 000 |
| 03596010436511 | K970751 | 000 |
| 03596010439796 | K970751 | 000 |
| 03596010439802 | K970751 | 000 |
| 03596010439826 | K970751 | 000 |
| 03596010441744 | K970751 | 000 |
| 03596010454430 | K970751 | 000 |
| 03596010439819 | K970751 | 000 |