FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOMET VISION FOOTRING SYSTEM
K Number: K093057
·
Decision Dec 1, 2009
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
95
Review Days
62
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
- BIOMET VISION FOOTRING SYSTEM
- K Number
- K093057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ebi, L.P.
- Date Received
- September 30, 2009
- Decision Date
- December 1, 2009
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTT), ordered by most recent decision date.
MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
DYNEX® External Fixation Systems
FDA 510(k)
FDA Class 2
·Orthopedic
QuikFix External Fixator: Knee-Spanning Pack
FDA 510(k)
FDA Class 2
·Orthopedic
Excelsior System
FDA 510(k)
FDA Class 2
·Orthopedic
Hoffmann LRF System
FDA 510(k)
FDA Class 2
·Orthopedic
Monkey Rings External Ring Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Ebi, L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K100438 | POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM | Jun 23, 2010 | Substantially Equivalent |
| K100220 | POLARIS SPINAL SYSTEM | May 17, 2010 | Substantially Equivalent |
| K093880 | PEANUT GROWTH CONTROL PLATING SYSTEM | Apr 16, 2010 | Substantially Equivalent |
| K092574 | ESL SPINAL SYSTEM | Feb 4, 2010 | Substantially Equivalent |
| K092336 | C-THRU SPINAL SYSTEM | Oct 15, 2009 | Substantially Equivalent |
| K091381 | IBEX SPINAL SYSTEM | Aug 7, 2009 | Substantially Equivalent |
| K090203 | 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS | Jul 30, 2009 | Substantially Equivalent |
| K090523 | POLARIS SPINAL SYSTEM | Jul 1, 2009 | Substantially Equivalent |
| K082406 | EXPANDABLE PEEK-OPTIMA IMPLANT | Jan 14, 2009 | Substantially Equivalent |
| K082187 | BIOMET ANTERIOR LUMBAR PLATE | Nov 13, 2008 | Substantially Equivalent |