FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRIMAL OK INTERSPINOUS FUSION SYSTEM
K Number: K100354
·
Decision Aug 17, 2010
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
29
Review Days
186
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Basic Information
- Device Name
- PRIMAL OK INTERSPINOUS FUSION SYSTEM
- K Number
- K100354
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed LP
- Date Received
- February 12, 2010
- Decision Date
- August 17, 2010
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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| K123207 | PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM | Nov 29, 2012 | Substantially Equivalent |
| K120015 | OSTEOMED WRIST PLATING SYSTEM | Apr 24, 2012 | Substantially Equivalent |
| K111419 | OSTEOMED HAND FUSION SYSTEM | Oct 7, 2011 | Substantially Equivalent |
| K111176 | OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM | Aug 15, 2011 | Substantially Equivalent |
| K102438 | PRIMALOK FACET FIXATION SYSTEM | Sep 30, 2010 | Substantially Equivalent |
| K091614 | OSTEOMED FOOT PLATING SYSTEM | Sep 10, 2009 | Substantially Equivalent |