The following data is part of a premarket notification filed by Mitek Worldwide with the FDA for Bio-intrafix Tibial Screw And Sheath.
| Device ID | K032167 |
| 510k Number | K032167 |
| Device Name: | BIO-INTRAFIX TIBIAL SCREW AND SHEATH |
| Classification | Screw, Fixation, Bone |
| Applicant | MITEK WORLDWIDE A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVENUE Norwood, MA 02062 |
| Contact | Karen K Sylvia |
| Correspondent | Karen K Sylvia MITEK WORLDWIDE A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVENUE Norwood, MA 02062 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-16 |
| Decision Date | 2003-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705013432 | K032167 | 000 |
| 10886705013258 | K032167 | 000 |
| 10886705013241 | K032167 | 000 |
| 10886705013227 | K032167 | 000 |
| 10886705013210 | K032167 | 000 |
| 10886705013197 | K032167 | 000 |