FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPIX LUMBAR INTERBODY DEVICE
K Number: K100544
·
Decision Jul 22, 2010
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
14
Review Days
147
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Basic Information
- Device Name
- IMPIX LUMBAR INTERBODY DEVICE
- K Number
- K100544
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicrea Technologies
- Date Received
- February 25, 2010
- Decision Date
- July 22, 2010
- 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 Medicrea Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K102406 | PASS ANTERIOR SPINAL SYSTEM | Aug 23, 2011 | Substantially Equivalent |
| K083798 | IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF | May 19, 2010 | Substantially Equivalent |
| K100297 | PASS LP SPINAL SYSTEM | Mar 4, 2010 | Substantially Equivalent |
| K083810 | PASS LP SPINAL SYSTEM | Jul 31, 2009 | Substantially Equivalent |
| K083308 | PASS LP SPINAL SYSTEM | Dec 10, 2008 | Substantially Equivalent |
| K082069 | PASS 2 SPINAL SYSTEM | Oct 3, 2008 | Substantially Equivalent |
| K082577 | PASS LP SPINAL SYSTEM | Oct 3, 2008 | Substantially Equivalent |
| K080099 | PASS SPINAL SYSTEM | Apr 9, 2008 | Substantially Equivalent |
| K072226 | IMPIX SPACER | Dec 10, 2007 | Substantially Equivalent |
| K070530 | MODIFICATION TO PASSMED SPINAL SYSTEM | Oct 18, 2007 | Substantially Equivalent |