FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PASS LP SPINAL SYSTEM
K Number: K100297
·
Decision Mar 4, 2010
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
14
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PASS LP SPINAL SYSTEM
- K Number
- K100297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicrea Technologies
- Date Received
- February 2, 2010
- Decision Date
- March 4, 2010
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNI), ordered by most recent decision date.
Mikron Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
LumFix Spinal Fixation Sytem
FDA 510(k)
FDA Class 2
·Orthopedic
Double Medical Universal Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
MySpine Pedicle Screw Placement Guides - LP
FDA 510(k)
FDA Class 2
·Orthopedic
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Premier
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Medicrea Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K102406 | PASS ANTERIOR SPINAL SYSTEM | Aug 23, 2011 | Substantially Equivalent |
| K100544 | IMPIX LUMBAR INTERBODY DEVICE | Jul 22, 2010 | Substantially Equivalent |
| K083798 | IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF | May 19, 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 |