The following data is part of a premarket notification filed by Altiva Corp. with the FDA for Arctec Semirigid Plating System.
| Device ID | K051044 |
| 510k Number | K051044 |
| Device Name: | ARCTEC SEMIRIGID PLATING SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ALTIVA CORP. 9800-I SOUTHERN PINE BLVD. Charlotte, NC 28273 |
| Contact | John Kaptian |
| Correspondent | John Kaptian ALTIVA CORP. 9800-I SOUTHERN PINE BLVD. Charlotte, NC 28273 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-25 |
| Decision Date | 2005-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841193101125 | K051044 | 000 |
| 00841193101248 | K051044 | 000 |
| 00841193101255 | K051044 | 000 |
| 00841193101262 | K051044 | 000 |
| 00841193101279 | K051044 | 000 |
| 00841193101286 | K051044 | 000 |
| 00841193101293 | K051044 | 000 |
| 00841193101309 | K051044 | 000 |
| 00841193101316 | K051044 | 000 |
| 00841193101231 | K051044 | 000 |
| 00841193101224 | K051044 | 000 |
| 00841193101217 | K051044 | 000 |
| 00841193101132 | K051044 | 000 |
| 00841193101149 | K051044 | 000 |
| 00841193101156 | K051044 | 000 |
| 00841193101163 | K051044 | 000 |
| 00841193101170 | K051044 | 000 |
| 00841193101187 | K051044 | 000 |
| 00841193101194 | K051044 | 000 |
| 00841193101200 | K051044 | 000 |
| 00841193101323 | K051044 | 000 |
| 00841193101330 | K051044 | 000 |
| 00841193101347 | K051044 | 000 |
| 00841193102443 | K051044 | 000 |
| 00841193102450 | K051044 | 000 |
| 00841193102467 | K051044 | 000 |
| 00841193102474 | K051044 | 000 |
| 00841193102481 | K051044 | 000 |
| 00841193102498 | K051044 | 000 |
| 00841193103099 | K051044 | 000 |
| 00841193120461 | K051044 | 000 |
| 00841193102436 | K051044 | 000 |
| 00841193102429 | K051044 | 000 |
| 00841193102412 | K051044 | 000 |
| 00841193101354 | K051044 | 000 |
| 00841193101576 | K051044 | 000 |
| 00841193101583 | K051044 | 000 |
| 00841193101590 | K051044 | 000 |
| 00841193101606 | K051044 | 000 |
| 00841193101613 | K051044 | 000 |
| 00841193101620 | K051044 | 000 |
| 00841193101637 | K051044 | 000 |
| 00841193120478 | K051044 | 000 |