The following data is part of a premarket notification filed by Blue Sky Bio, Llc with the FDA for Blue Sky Bio Zygomatic Implant System.
| Device ID | K153064 |
| 510k Number | K153064 |
| Device Name: | Blue Sky Bio Zygomatic Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 Grayslake, IL 60030 |
| Contact | Michele Vovolka |
| Correspondent | Kevin A Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-22 |
| Decision Date | 2016-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810060220276 | K153064 | 000 |
| 00810060220191 | K153064 | 000 |
| 00810060220207 | K153064 | 000 |
| 00810060220214 | K153064 | 000 |
| 00810060220221 | K153064 | 000 |
| 00810060220238 | K153064 | 000 |
| 00810060220245 | K153064 | 000 |
| 00810060220252 | K153064 | 000 |
| 00810060220269 | K153064 | 000 |
| 00810060220283 | K153064 | 000 |