The following data is part of a premarket notification filed by Biogennix, Llc with the FDA for Sypher Spacer System.
| Device ID | K141798 |
| 510k Number | K141798 |
| Device Name: | SYPHER SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | BIOGENNIX, LLC 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Contact | Meredith May, Ms, Rac |
| Correspondent | Meredith May, Ms, Rac BIOGENNIX, LLC 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-03 |
| Decision Date | 2015-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812593020002 | K141798 | 000 |
| 00812593020125 | K141798 | 000 |
| 00812593020132 | K141798 | 000 |
| 00812593020149 | K141798 | 000 |
| 00812593020156 | K141798 | 000 |
| 00812593020163 | K141798 | 000 |
| 00812593020170 | K141798 | 000 |
| 00812593020187 | K141798 | 000 |
| 00812593020194 | K141798 | 000 |
| 00812593020118 | K141798 | 000 |
| 00812593020101 | K141798 | 000 |
| 00812593020095 | K141798 | 000 |
| 00812593020019 | K141798 | 000 |
| 00812593020026 | K141798 | 000 |
| 00812593020033 | K141798 | 000 |
| 00812593020040 | K141798 | 000 |
| 00812593020057 | K141798 | 000 |
| 00812593020064 | K141798 | 000 |
| 00812593020071 | K141798 | 000 |
| 00812593020088 | K141798 | 000 |
| 00812593020200 | K141798 | 000 |
| 00812593020217 | K141798 | 000 |
| 00812593020224 | K141798 | 000 |
| 00812593020484 | K141798 | 000 |
| 00812593020491 | K141798 | 000 |
| 00812593020507 | K141798 | 000 |
| 00812593020514 | K141798 | 000 |
| 00812593020521 | K141798 | 000 |
| 00812593020538 | K141798 | 000 |
| 00812593020545 | K141798 | 000 |
| 00812593020552 | K141798 | 000 |
| 00812593020330 | K141798 | 000 |
| 00812593020323 | K141798 | 000 |
| 00812593020316 | K141798 | 000 |
| 00812593020231 | K141798 | 000 |
| 00812593020248 | K141798 | 000 |
| 00812593020255 | K141798 | 000 |
| 00812593020262 | K141798 | 000 |
| 00812593020279 | K141798 | 000 |
| 00812593020286 | K141798 | 000 |
| 00812593020293 | K141798 | 000 |
| 00812593020309 | K141798 | 000 |
| 00812593020569 | K141798 | 000 |