FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
K Number: K091190
·
Decision Jul 30, 2009
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
38
Review Days
98
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Basic Information
- Device Name
- UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
- K Number
- K091190
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zimmer Spine, Inc.
- Date Received
- April 23, 2009
- Decision Date
- July 30, 2009
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Zimmer Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K153631 | Zimmer Virage OCT Spinal Fixation System | Feb 16, 2016 | Substantially Equivalent |
| K150896 | Vitality Spinal Fixation System | Aug 31, 2015 | Substantially Equivalent |
| K151031 | Virage OCT Spinal Fixation System | Jun 24, 2015 | Substantially Equivalent |
| K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System | Jun 18, 2015 | Substantially Equivalent |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System | Mar 20, 2015 | Substantially Equivalent |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) | Feb 12, 2015 | Substantially Equivalent |
| K142053 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | Oct 29, 2014 | Substantially Equivalent |
| K141500 | OPTIO-C ANTERIOR CERVICAL SYSTEM | Sep 23, 2014 | Substantially Equivalent |
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | Jun 2, 2014 | Substantially Equivalent |
| K140611 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM | May 21, 2014 | Substantially Equivalent |