Zodiac Polyaxial Spinal Fixation System
FDA 510(k) K042673 · Alphatec/Nexmed
510(k) numberK042673
Submission
- Device name
- Zodiac Polyaxial Spinal Fixation System
- Applicant
- Alphatec/Nexmed
Carlsbad, CA, US - Received
- September 29, 2004
- Decision date
- October 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K050830 | Zodiac Spinal Fixation SystemKWP · Traditional | 06/22/2005SE |
| K051286 | Zodiac Spinal Fixation SystemMNH · Special | 06/17/2005SE |
| K050553 | Novel VBR Spinal SystemMQP · Special | 04/18/2005SE |
| K050390 | Tamarack Anterior ThoracolunbarKWQ · Traditional | 03/14/2005SE |
| K050078 | Roc Lumbar Plating SystemMNH · Traditional | 02/18/2005SE |
| K042252 | Nexflex Total Hip SystemLPH · Special | 12/06/2004SE |
| K042440 | Alphatec Femoral Trochanteric Nail (FTN) SystemHSB · Traditional | 10/07/2004SE |
| K042201 | Novel VBR Spinal SystemMQP · Traditional | 10/07/2004SE |
Questions and answers
When was Zodiac Polyaxial Spinal Fixation System cleared by the FDA?
Zodiac Polyaxial Spinal Fixation System (K042673) received a 510(k) decision of Substantially Equivalent on October 27, 2004, 28 days after the submission was received.
What is the product code of K042673?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.