The following data is part of a premarket notification filed by Newdeal Sas with the FDA for Panta Nail (dia. 10mm), Panta Nail Xl.
| Device ID | K091788 |
| 510k Number | K091788 |
| Device Name: | PANTA NAIL (DIA. 10MM), PANTA NAIL XL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | NEWDEAL SAS 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Judith O'grady |
| Correspondent | Judith O'grady NEWDEAL SAS 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-17 |
| Decision Date | 2009-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M248510005ND1 | K091788 | 000 |
| M248500080ND1 | K091788 | 000 |
| M248510111ND1 | K091788 | 000 |
| M248510141ND1 | K091788 | 000 |
| M248510211ND1 | K091788 | 000 |
| M248510241ND1 | K091788 | 000 |
| M248510311ND1 | K091788 | 000 |
| M248510341ND1 | K091788 | 000 |
| M248510004ND1 | K091788 | 000 |
| M248500050ND1 | K091788 | 000 |