The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for S2 Tibial Nail.
| Device ID | K021027 |
| 510k Number | K021027 |
| Device Name: | S2 TIBIAL NAIL |
| 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 | 2002-03-29 |
| Decision Date | 2002-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540397263 | K021027 | 000 |
| 04546540396099 | K021027 | 000 |
| 04546540396082 | K021027 | 000 |
| 04546540395399 | K021027 | 000 |
| 04546540395382 | K021027 | 000 |
| 04546540395351 | K021027 | 000 |
| 04546540395344 | K021027 | 000 |
| 04546540395313 | K021027 | 000 |
| 04546540395306 | K021027 | 000 |
| 04546540395269 | K021027 | 000 |
| 04546540395252 | K021027 | 000 |
| 04546540395221 | K021027 | 000 |
| 04546540395214 | K021027 | 000 |
| 04546540395184 | K021027 | 000 |
| 04546540396129 | K021027 | 000 |
| 04546540396136 | K021027 | 000 |
| 04546540397256 | K021027 | 000 |
| 04546540397225 | K021027 | 000 |
| 04546540397218 | K021027 | 000 |
| 04546540397188 | K021027 | 000 |
| 04546540397171 | K021027 | 000 |
| 04546540396303 | K021027 | 000 |
| 04546540396297 | K021027 | 000 |
| 04546540396266 | K021027 | 000 |
| 04546540396259 | K021027 | 000 |
| 04546540396228 | K021027 | 000 |
| 04546540396211 | K021027 | 000 |
| 04546540396174 | K021027 | 000 |
| 04546540396167 | K021027 | 000 |
| 04546540395177 | K021027 | 000 |