510(k) K033090 ยท KWP Appliance, Fixation, Spinal Interlaminal
ICON POLYAXIAL PEDICLE SCREW SYSTEM
| Applicant | Alphatec Mfg., Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Mar 26, 2004 |
| Received | Sep 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033090
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2012 | Alphatec Spine, Inc. TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55.
Subsequent Product Codes: MNH, MNI.
The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.