FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
K Number: K130478
·
Decision Jul 26, 2013
Classifications
1
FEI Numbers
422
Registration Numbers
422
Same Product Code
869
Applicant Total
42
Review Days
151
Basic Information
- Device Name
- SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
- K Number
- K130478
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GLOBUS MEDICAL, INC.
- Date Received
- February 25, 2013
- Decision Date
- July 26, 2013
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by GLOBUS MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K162825 | CAPTIVATE Compression Screws | May 1, 2017 | Substantially Equivalent |
| K162618 | CONCORD Plus Radiopaque Bone Cement | Jan 23, 2017 | Substantially Equivalent |
| K161379 | ELSA Spacers | Sep 29, 2016 | Substantially Equivalent |
| K133678 | CONFIRM BIOACTIVE | Aug 26, 2014 | Substantially Equivalent |
| K133482 | SILC FIXATION SYSTEM | May 21, 2014 | Substantially Equivalent |
| K133350 | REVERE STABILIZATION SYSTEM | Mar 11, 2014 | Substantially Equivalent |
| K132191 | SP-FIX SPINOUS PROCESS FIXATION PLATE | Nov 22, 2013 | Substantially Equivalent |
| K131449 | COALITION SPACER | Jul 30, 2013 | Substantially Equivalent |
| K123783 | ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS | Mar 14, 2013 | Substantially Equivalent |
| K122097 | PATRIOT SPACERS | Dec 6, 2012 | Substantially Equivalent |