The following data is part of a premarket notification filed by T.a.g. Medical Products Corporation, Ltd. with the FDA for Latarjet Cortical Screw Set.
| Device ID | K110763 |
| 510k Number | K110763 |
| Device Name: | LATARJET CORTICAL SCREW SET |
| Classification | Screw, Fixation, Bone |
| Applicant | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-18 |
| Decision Date | 2011-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705020720 | K110763 | 000 |
| 10886705020638 | K110763 | 000 |
| 10886705020645 | K110763 | 000 |
| 10886705020652 | K110763 | 000 |
| 10886705020669 | K110763 | 000 |
| 10886705020676 | K110763 | 000 |
| 10886705020683 | K110763 | 000 |
| 10886705020690 | K110763 | 000 |
| 10886705020706 | K110763 | 000 |
| 10886705020713 | K110763 | 000 |
| 10886705020621 | K110763 | 000 |