FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XIA SPINAL SYSTEM
K Number: K022160
·
Decision Aug 1, 2002
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
13
Review Days
29
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
- XIA SPINAL SYSTEM
- K Number
- K022160
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica Osteonics
- Date Received
- July 3, 2002
- Decision Date
- August 1, 2002
- 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 Howmedica Osteonics
| K Number | Device Name | ||
|---|---|---|---|
| K120578 | ACCOLADE II HIP STEM | Mar 29, 2012 | Substantially Equivalent |
| K102019 | RESTORATION ACETABULAR WEDGE AUGMENTS | Mar 3, 2011 | Substantially Equivalent |
| K063423 | TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT | Jan 22, 2007 | Substantially Equivalent |
| K033258 | BONESAVE BONE VOID FILLER | Mar 9, 2004 | Substantially Equivalent |
| K032855 | STRYKER SPINE MAPS SYSTEM | Dec 10, 2003 | Substantially Equivalent |
| K031702 | REFLEX ANTERIOR CERVICAL PLATE SYSTEM | Aug 8, 2003 | Substantially Equivalent |
| K031435 | BONESOURCE BVF | Aug 4, 2003 | Substantially Equivalent |
| K031217 | GMRS PRESS FIT STEMS WITH PUREFIX HA | May 23, 2003 | Substantially Equivalent |
| K022461 | S2 FEMORAL NAIL | Aug 22, 2002 | Substantially Equivalent |
| K013772 | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | Dec 3, 2001 | Substantially Equivalent |