FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM
K Number: K070341
·
Decision Aug 8, 2007
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
25
Review Days
183
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Basic Information
- Device Name
- LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM
- K Number
- K070341
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ldr Spine USA
- Date Received
- February 6, 2007
- Decision Date
- August 8, 2007
- Product Code
- KWP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K151934 | ROI-C Titanium-Coated Implant System | Dec 7, 2015 | Substantially Equivalent |
| K150765 | LDR Spine ROI-C Cervical Cage System | Sep 17, 2015 | Substantially Equivalent |
| K110327 | LDR SPINE ROI-A INTERBODY FUSION SYSTEM | Sep 30, 2011 | Substantially Equivalent |
| K102331 | LDR SPINE USA SPINETUNE TL SPINAL SYSTEM | Oct 15, 2010 | Substantially Equivalent |
| K102265 | LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM | Sep 29, 2010 | Substantially Equivalent |
| K100575 | LDR SPINE USA SPINE TUNE TL SPINE SYSTEM | Mar 31, 2010 | Substantially Equivalent |
| K091088 | LDR SPINE CERVICAL INTERBODY FUSION SYSTEM | Jul 14, 2009 | Substantially Equivalent |
| K090507 | MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM | Jun 25, 2009 | Substantially Equivalent |