Low Profile Sleave Nut Assembly
FDA 510(k) K931208 · Advanced Spine Fixation Systems, Inc.
510(k) numberK931208
Submission
- Device name
- Low Profile Sleave Nut Assembly
- Applicant
- Advanced Spine Fixation Systems, Inc.
Cypress, CA, US - Received
- March 10, 1993
- Decision date
- March 28, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
| K954770 | Centra-Line Grapple, Varifix SystemKWP · Traditional | 01/25/1996SE |
| 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 |
Questions and answers
When was Low Profile Sleave Nut Assembly cleared by the FDA?
Low Profile Sleave Nut Assembly (K931208) received a 510(k) decision of Substantially Equivalent for Some Indications on March 28, 1994, 383 days after the submission was received.
What is the product code of K931208?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.