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 |