Centra-Line Grapple, Varifix System
FDA 510(k) K954770 · Advanced Spine Fixation Systems, Inc.
510(k) numberK954770
Submission
- Device name
- Centra-Line Grapple, Varifix System
- Applicant
- Advanced Spine Fixation Systems, Inc.
Cypress, CA, US - Received
- October 17, 1995
- Decision date
- January 25, 1996
- 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 |
|---|---|---|
| K992012 | Wiltse SystemKWQ · Traditional | 02/04/2000SE |
| K990845 | Modification to Parts Numbered Cgt-Sl and CGT-SL-15KWP · Special | 04/13/1999SE |
| K953779 | Saddle with Anchor, Stainless Steel Varifix SystemMNH · Traditional | 11/07/1995SN |
| K953778 | Saddle with Anchor, Titanium Varifix SystemMNH · Traditional | 11/06/1995SN |
| K953369 | Stainless Steel Varifix System 5.0MM Diameter Anchor ScrewMNH · Traditional | 09/08/1995SN |
| K951308 | 5.8MM Diameter Anchor ScrewMNH · Traditional | 07/26/1995SN |
| K951172 | Titanium Low Profile Cross BarMNH · Traditional | 07/25/1995SE |
| K945064 | Selby InstrumentationMNH · Traditional | 04/26/1995SE |
| K943775 | Selby InstrumentationMNH · Traditional | 04/26/1995SN |
| K942387 | Selby InstrumentationMNH · Traditional | 02/14/1995SN |
Questions and answers
When was Centra-Line Grapple, Varifix System cleared by the FDA?
Centra-Line Grapple, Varifix System (K954770) received a 510(k) decision of Substantially Equivalent on January 25, 1996, 100 days after the submission was received.
What is the product code of K954770?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.