The following data is part of a premarket notification filed by Medtronic with the FDA for Kyphon Xpander Ii Inflatable Bone Tamp.
| Device ID | K101864 |
| 510k Number | K101864 |
| Device Name: | KYPHON XPANDER II INFLATABLE BONE TAMP |
| Classification | Arthroscope |
| Applicant | Medtronic 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Contact | Heinz Steneberg |
| Correspondent | Heinz Steneberg Medtronic 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 | 2010-07-02 |
| Decision Date | 2010-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000557164 | K101864 | 000 |
| 00763000025731 | K101864 | 000 |
| 00763000026974 | K101864 | 000 |
| 00763000026981 | K101864 | 000 |
| 00763000026998 | K101864 | 000 |
| 00763000027018 | K101864 | 000 |
| 00763000027025 | K101864 | 000 |
| 00763000027032 | K101864 | 000 |
| 00763000031541 | K101864 | 000 |
| 00763000025717 | K101864 | 000 |
| 00763000025694 | K101864 | 000 |
| 00763000557744 | K101864 | 000 |
| 00763000557669 | K101864 | 000 |
| 00763000557676 | K101864 | 000 |
| 00763000557683 | K101864 | 000 |
| 00763000557690 | K101864 | 000 |
| 00763000557706 | K101864 | 000 |
| 00763000557713 | K101864 | 000 |
| 00763000557720 | K101864 | 000 |
| 00763000557737 | K101864 | 000 |
| 00763000031558 | K101864 | 000 |
| 00763000031565 | K101864 | 000 |
| 00763000031589 | K101864 | 000 |
| 00643169096493 | K101864 | 000 |
| 00643169096509 | K101864 | 000 |
| 00643169096516 | K101864 | 000 |
| 00643169096523 | K101864 | 000 |
| 00643169096530 | K101864 | 000 |
| 00643169096547 | K101864 | 000 |
| 00643169096554 | K101864 | 000 |
| 00643169096561 | K101864 | 000 |
| 00643169096486 | K101864 | 000 |
| 00643169096479 | K101864 | 000 |
| 00643169096462 | K101864 | 000 |
| 00763000031602 | K101864 | 000 |
| 00763000031626 | K101864 | 000 |
| 00613994962348 | K101864 | 000 |
| 00613994962362 | K101864 | 000 |
| 00643169093638 | K101864 | 000 |
| 00643169093645 | K101864 | 000 |
| 00643169093652 | K101864 | 000 |
| 00643169093676 | K101864 | 000 |
| 00643169096578 | K101864 | 000 |