The following data is part of a premarket notification filed by Medtronic Spine Llc with the FDA for Kyphon Inflation Syringe.
| Device ID | K103231 |
| 510k Number | K103231 |
| Device Name: | KYPHON INFLATION SYRINGE |
| Classification | Arthroscope |
| Applicant | MEDTRONIC SPINE LLC 1221 Crossman Ave Sunnyvale, CA 94089 |
| Contact | Hetal Jawahar Thakker |
| Correspondent | Hetal Jawahar Thakker MEDTRONIC SPINE LLC 1221 Crossman Ave Sunnyvale, CA 94089 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2011-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169097155 | K103231 | 000 |
| 00643169671645 | K103231 | 000 |
| 00643169671669 | K103231 | 000 |
| 00643169671683 | K103231 | 000 |
| 00643169671706 | K103231 | 000 |
| 00643169671720 | K103231 | 000 |
| 00643169671744 | K103231 | 000 |
| 00643169671768 | K103231 | 000 |
| 00643169671782 | K103231 | 000 |
| 00643169671805 | K103231 | 000 |
| 00643169671829 | K103231 | 000 |
| 00643169671843 | K103231 | 000 |
| 00643169671621 | K103231 | 000 |