LDR Spine Easyspine Posterior Osteosynthesis System
FDA 510(k) K070341 · Ldr Spine USA
510(k) numberK070341
Submission
- Device name
- LDR Spine Easyspine Posterior Osteosynthesis System
- Applicant
- Ldr Spine USA
Austin, TX, US - Received
- February 6, 2007
- Decision date
- August 8, 2007
- 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 |
|---|---|---|
| K162133 | VerteFIT Corpectomy Cage SystemMQP · Traditional | 05/16/2017SE |
| K161173 | Avenue® T TLIF CageOVD · Traditional | 09/28/2016SE |
| K161798 | FacetBRIDGE® SystemMRW · Special | 08/04/2016SE |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…MAX · Traditional | 03/31/2016SE |
| K152137 | FacetBRIDGE SystemMRW · Traditional | 01/25/2016SE |
| K151934 | ROI-C Titanium-Coated Implant SystemOVE · Traditional | 12/07/2015SE |
| K150765 | LDR Spine ROI-C Cervical Cage SystemOVE · Traditional | 09/17/2015SE |
| K142645 | Avenue T TLIF CageOVD · Traditional | 06/11/2015SE |
| K133363 | Interbridge Interspinous Posterior Fixation SystemPEK · Traditional | 03/07/2014SE |
| K123134 | Easyspine SystemNKB · Traditional | 02/01/2013SE |
Questions and answers
When was LDR Spine Easyspine Posterior Osteosynthesis System cleared by the FDA?
LDR Spine Easyspine Posterior Osteosynthesis System (K070341) received a 510(k) decision of Substantially Equivalent on August 8, 2007, 183 days after the submission was received.
What is the product code of K070341?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.