The following data is part of a premarket notification filed by Tag Medical Corp. with the FDA for The Grapplr And Grapplr Extender.
| Device ID | K101616 |
| 510k Number | K101616 |
| Device Name: | THE GRAPPLR AND GRAPPLR EXTENDER |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | TAG MEDICAL CORP. 291 Hillside Avenue Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub TAG MEDICAL CORP. 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-09 |
| Decision Date | 2011-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818674025758 | K101616 | 000 |
| 10818674025741 | K101616 | 000 |
| 10818674025734 | K101616 | 000 |
| 10818674025727 | K101616 | 000 |
| 10818674025710 | K101616 | 000 |