The following data is part of a premarket notification filed by Newdeal Sas with the FDA for Newdeal Hallu Lock Plate System.
| Device ID | K083154 |
| 510k Number | K083154 |
| Device Name: | NEWDEAL HALLU LOCK PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-24 |
| Decision Date | 2009-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M248290660SND1 | K083154 | 000 |
| M248290345SND1 | K083154 | 000 |
| 10381780044154 | K083154 | 000 |
| 10381780044147 | K083154 | 000 |
| 10381780044130 | K083154 | 000 |
| M248290255SND1 | K083154 | 000 |
| 10381780044116 | K083154 | 000 |
| 10381780044109 | K083154 | 000 |
| 10381780044093 | K083154 | 000 |
| 10381780044086 | K083154 | 000 |
| 10381780044079 | K083154 | 000 |
| 10381780044178 | K083154 | 000 |
| M248290435SND1 | K083154 | 000 |
| M248290655SND1 | K083154 | 000 |
| 10381780044277 | K083154 | 000 |
| M248290645SND1 | K083154 | 000 |
| 10381780044253 | K083154 | 000 |
| M248290555SND1 | K083154 | 000 |
| 10381780044239 | K083154 | 000 |
| M248290545SND1 | K083154 | 000 |
| 10381780044215 | K083154 | 000 |
| M248290445SND1 | K083154 | 000 |
| 10381780044192 | K083154 | 000 |
| 10381780044062 | K083154 | 000 |