The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Llc with the FDA for Boundary Anterior Lumbar Buttress Plate.
| Device ID | K173091 |
| 510k Number | K173091 |
| Device Name: | Boundary Anterior Lumbar Buttress Plate |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Nvision Biomedical Technologies, LLC 1350 N Loop 1604 E, Suite 103 San Antonio, TX 78232 |
| Contact | Diana L. Langham |
| Correspondent | Allison C. Komiyama, Ph.d., R.a.c. AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814008029808 | K173091 | 000 |
| 90814008025407 | K173091 | 000 |
| 90814008025391 | K173091 | 000 |
| 90814008025384 | K173091 | 000 |
| 90814008025377 | K173091 | 000 |
| 90814008025360 | K173091 | 000 |
| 90814008025353 | K173091 | 000 |
| 90814008025346 | K173091 | 000 |
| 90814008025339 | K173091 | 000 |
| 90814008025322 | K173091 | 000 |
| 00810005665247 | K173091 | 000 |
| 00810005665230 | K173091 | 000 |
| 00810005665223 | K173091 | 000 |
| 00810005665216 | K173091 | 000 |
| 00810005665209 | K173091 | 000 |
| 00810005665193 | K173091 | 000 |
| 00810005665186 | K173091 | 000 |
| 90814008025414 | K173091 | 000 |
| 90814008025421 | K173091 | 000 |
| 00814008025589 | K173091 | 000 |
| 00814008025572 | K173091 | 000 |
| 00814008025565 | K173091 | 000 |
| 00814008025558 | K173091 | 000 |
| 00814008025541 | K173091 | 000 |
| 90814008025537 | K173091 | 000 |
| 90814008025520 | K173091 | 000 |
| 90814008025513 | K173091 | 000 |
| 90814008025506 | K173091 | 000 |
| 90814008025490 | K173091 | 000 |
| 90814008025483 | K173091 | 000 |
| 90814008025476 | K173091 | 000 |
| 90814008025469 | K173091 | 000 |
| 90814008025452 | K173091 | 000 |
| 90814008025445 | K173091 | 000 |
| 90814008025438 | K173091 | 000 |
| 00810005665179 | K173091 | 000 |