The following data is part of a premarket notification filed by T.a.g. Medical Products with the FDA for Modification To:latarjet Cortical Screw Set, Models 523jt, 523j (36-48mm).
| Device ID | K091694 |
| 510k Number | K091694 |
| Device Name: | MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) |
| Classification | Screw, Fixation, Bone |
| Applicant | T.A.G. MEDICAL PRODUCTS 291 Hillside Avenue Somerset, MA 02726 |
| Contact | Georgie J Hattub |
| Correspondent | Georgie J Hattub T.A.G. MEDICAL PRODUCTS 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 | 2009-06-10 |
| Decision Date | 2009-07-07 |
| Summary: | summary |