FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAMARACK ANTERIOR THORACOLUNBAR
K Number: K050390
·
Decision Mar 14, 2005
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
9
Review Days
26
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Basic Information
- Device Name
- TAMARACK ANTERIOR THORACOLUNBAR
- K Number
- K050390
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alphatec/Nexmed
- Date Received
- February 16, 2005
- Decision Date
- March 14, 2005
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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Other Clearances by Alphatec/Nexmed
| K Number | Device Name | ||
|---|---|---|---|
| K050830 | ZODIAC SPINAL FIXATION SYSTEM | Jun 22, 2005 | Substantially Equivalent |
| K051286 | ZODIAC SPINAL FIXATION SYSTEM | Jun 17, 2005 | Substantially Equivalent |
| K050553 | NOVEL VBR SPINAL SYSTEM | Apr 18, 2005 | Substantially Equivalent |
| K050078 | ROC LUMBAR PLATING SYSTEM | Feb 18, 2005 | Substantially Equivalent |
| K042252 | NEXFLEX TOTAL HIP SYSTEM | Dec 6, 2004 | Substantially Equivalent |
| K042673 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | Oct 27, 2004 | Substantially Equivalent |
| K042201 | NOVEL VBR SPINAL SYSTEM | Oct 7, 2004 | Substantially Equivalent |
| K042440 | ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM | Oct 7, 2004 | Substantially Equivalent |