Icon Polyaxial Pedicle Screw System
FDA 510(k) K033090 · Alphatec Mfg., Inc.
510(k) numberK033090
Submission
- Device name
- Icon Polyaxial Pedicle Screw System
- Applicant
- Alphatec Mfg., Inc.
Carlsbad, CA, US - Received
- September 29, 2003
- Decision date
- March 26, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation SystemKWP · Traditional | L&K BIOMED Co., Ltd. | 07/29/2015SE |
| K150753 | OASYS SystemKWP · Traditional | Stryker Corporation | 06/09/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | Precision Spine, Inc. | 06/04/2015SE |
| K142867 | Reliance Posterior Cervical-Thoracic SystemKWP · Special | Reliance Medical Systems, LLC | 04/29/2015SE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 04/28/2015SE |
| K142253 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/23/2015SE |
| K150229 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K143249 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K142741 | OASYS SystemKWP · Traditional | Stryker Corporation | 01/15/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | K2m | 12/22/2014SE |
More from K2m
| 510(k) | Device | Decision |
|---|---|---|
| K023299 | Alpha Mirage Top Tightening Spinal SystemMNI · Traditional | 12/11/2002SE |
| K020356 | Alpha Mirage Top Tightening Spinal SystemMNH · Traditional | 07/23/2002SE |
| K993513 | Deltaloc Anterior Cervical Plate SystemKWQ · Traditional | 04/26/2000SE |
| K993873 | Alphatec External Fixation System Compression/Distraction RodKTT · Traditional | 01/03/2000SE |
| K992350 | Pylon Intramedullaary Nail SystemHSB · Traditional | 09/22/1999SE |
| K980788 | Alphatec Wire External Fixation SystemJDW · Traditional | 05/22/1998SE |
| K964400 | Alphatec External Fixation SystemKTT · Traditional | 04/28/1997SE |
| K951846 | Mirage Spinal System for Severe SpondylolisthesisKWP · Traditional | 02/14/1996SN |
| K926417 | Alphatec 130-150 Slotted Compression Hip ScrewKTT · Traditional | 09/28/1994SE |
| K930515 | Alpha Spinal SystemKWP · Traditional | 06/29/1994SESK |
Questions and answers
When was Icon Polyaxial Pedicle Screw System cleared by the FDA?
Icon Polyaxial Pedicle Screw System (K033090) received a 510(k) decision of Substantially Equivalent on March 26, 2004, 179 days after the submission was received.
What is the product code of K033090?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.