The following data is part of a premarket notification filed by Medtronic with the FDA for Kyphon Express Ii Inflatable Bone Tamps.
| Device ID | K123771 |
| 510k Number | K123771 |
| Device Name: | KYPHON EXPRESS II INFLATABLE BONE TAMPS |
| Classification | Arthroscope |
| Applicant | Medtronic 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Contact | Hetal Jawahar Thakker |
| Correspondent | Hetal Jawahar Thakker Medtronic 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Product Code | HRX |
| Subsequent Product Code | HXG |
| Subsequent Product Code | NDN |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-07 |
| Decision Date | 2012-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169143791 | K123771 | 000 |
| 00763000312053 | K123771 | 000 |
| 00763000557652 | K123771 | 000 |
| 00763000557645 | K123771 | 000 |
| 00763000557638 | K123771 | 000 |
| 00763000557157 | K123771 | 000 |
| 00763000557140 | K123771 | 000 |
| 00763000557133 | K123771 | 000 |
| 00763000557126 | K123771 | 000 |
| 00763000557119 | K123771 | 000 |
| 00763000557102 | K123771 | 000 |
| 00763000557096 | K123771 | 000 |
| 00763000312015 | K123771 | 000 |
| 00763000312039 | K123771 | 000 |
| 00643169143777 | K123771 | 000 |
| 00643169143753 | K123771 | 000 |
| 00763000026967 | K123771 | 000 |
| 00763000026943 | K123771 | 000 |
| 00763000026936 | K123771 | 000 |
| 00763000026912 | K123771 | 000 |
| 00763000026905 | K123771 | 000 |
| 00763000026882 | K123771 | 000 |
| 00763000025670 | K123771 | 000 |
| 00763000025656 | K123771 | 000 |
| 00763000025632 | K123771 | 000 |
| 00763000557089 | K123771 | 000 |