The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for T2 Humeral Nail System.
| Device ID | K011529 |
| 510k Number | K011529 |
| Device Name: | T2 HUMERAL NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-17 |
| Decision Date | 2001-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540515445 | K011529 | 000 |
| 04546540201768 | K011529 | 000 |
| 04546540201751 | K011529 | 000 |
| 04546540201744 | K011529 | 000 |
| 04546540201737 | K011529 | 000 |
| 04546540201218 | K011529 | 000 |
| 04546540201201 | K011529 | 000 |
| 04546540201195 | K011529 | 000 |
| 04546540201188 | K011529 | 000 |
| 04546540201171 | K011529 | 000 |
| 04546540201164 | K011529 | 000 |
| 04546540201157 | K011529 | 000 |
| 04546540201140 | K011529 | 000 |
| 04546540201775 | K011529 | 000 |
| 04546540201782 | K011529 | 000 |
| 04546540515438 | K011529 | 000 |
| 04546540201898 | K011529 | 000 |
| 04546540201881 | K011529 | 000 |
| 04546540201874 | K011529 | 000 |
| 04546540201867 | K011529 | 000 |
| 04546540201850 | K011529 | 000 |
| 04546540201843 | K011529 | 000 |
| 04546540201836 | K011529 | 000 |
| 04546540201829 | K011529 | 000 |
| 04546540201812 | K011529 | 000 |
| 04546540201805 | K011529 | 000 |
| 04546540201799 | K011529 | 000 |
| 04546540201133 | K011529 | 000 |