The following data is part of a premarket notification filed by Surfix Technologies with the FDA for Surfix Knee Osteotomy System.
| Device ID | K041601 |
| 510k Number | K041601 |
| Device Name: | SURFIX KNEE OSTEOTOMY SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SURFIX TECHNOLOGIES 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin SURFIX TECHNOLOGIES 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780044413 | K041601 | 000 |
| 10381780051077 | K041601 | 000 |
| 10381780051084 | K041601 | 000 |
| 10381780051091 | K041601 | 000 |
| 10381780051107 | K041601 | 000 |
| 10381780051114 | K041601 | 000 |
| 10381780051121 | K041601 | 000 |
| 10381780051138 | K041601 | 000 |
| 10381780051145 | K041601 | 000 |
| 10381780051060 | K041601 | 000 |
| M248CC018ND1 | K041601 | 000 |
| 10381780044420 | K041601 | 000 |
| 10381780044437 | K041601 | 000 |
| 10381780044444 | K041601 | 000 |
| 10381780044451 | K041601 | 000 |
| 10381780044468 | K041601 | 000 |
| M248PTOGND1 | K041601 | 000 |
| 10381780051039 | K041601 | 000 |
| 10381780051046 | K041601 | 000 |
| M248CC045ND1 | K041601 | 000 |
| 10381780051169 | K041601 | 000 |
| 10381780051176 | K041601 | 000 |
| 10381780051282 | K041601 | 000 |
| 10381780051299 | K041601 | 000 |
| 10381780051305 | K041601 | 000 |
| 10381780051312 | K041601 | 000 |
| 10381780051329 | K041601 | 000 |
| 10381780051336 | K041601 | 000 |
| 10381780051343 | K041601 | 000 |
| 10381780051350 | K041601 | 000 |
| 10381780051275 | K041601 | 000 |
| 10381780051268 | K041601 | 000 |
| 10381780051183 | K041601 | 000 |
| 10381780051190 | K041601 | 000 |
| M248SP020ND1 | K041601 | 000 |
| 10381780051213 | K041601 | 000 |
| M248SP030ND1 | K041601 | 000 |
| 10381780051237 | K041601 | 000 |
| M248SP040ND1 | K041601 | 000 |
| 10381780051251 | K041601 | 000 |
| M248SP100ND1 | K041601 | 000 |