FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)
K Number: K950864
·
Decision Jul 31, 1995
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
10
Applicant Total
43
Review Days
154
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Basic Information
- Device Name
- GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)
- K Number
- K950864
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Acu Med, Inc.
- Date Received
- February 27, 1995
- Decision Date
- July 31, 1995
- Product Code
- LZJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZJ), ordered by most recent decision date.
ARTHROSURFACE TOEMOTION
FDA 510(k)
FDA Unclassified
·Unknown
THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
FDA 510(k)
FDA Unclassified
·Unknown
MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
TOTAL TOE SYSTEM II
FDA 510(k)
FDA Unclassified
·Unknown
KINETIK GREAT TOE SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
OSTEOMED GREAT TOE SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
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| K963026 | TBD | Oct 28, 1996 | Substantially Equivalent |