The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Kyphon Element Inflatable Bone Tamp.
| Device ID | K151532 |
| 510k Number | K151532 |
| Device Name: | KYPHON ELEMENT Inflatable Bone Tamp |
| Classification | Arthroscope |
| Applicant | MEDTRONIC, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Pamela Edwards |
| Correspondent | Pamela Edwards MEDTRONIC, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-08 |
| Decision Date | 2015-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169582217 | K151532 | 000 |
| 00763000025823 | K151532 | 000 |