FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
PRIMALOK FACET FIXATION SYSTEM
K Number: K102438
·
Decision Sep 30, 2010
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
29
Review Days
35
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Basic Information
- Device Name
- PRIMALOK FACET FIXATION SYSTEM
- K Number
- K102438
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed LP
- Date Received
- August 26, 2010
- Decision Date
- September 30, 2010
- Product Code
- MRW
- 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 |
|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | FDA unclassified | Unknown |
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Other Clearances by Osteomed LP
| K Number | Device Name | ||
|---|---|---|---|
| K143338 | Argulated Locking Plates | Apr 1, 2015 | Substantially Equivalent |
| K133691 | EXTRIMILOCK ANKLE PLATING SYSTEM | Feb 24, 2014 | Substantially Equivalent |
| K131445 | OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM | Jun 18, 2013 | Substantially Equivalent |
| K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | Jun 3, 2013 | Substantially Equivalent |
| 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 |
| K100354 | PRIMAL OK INTERSPINOUS FUSION SYSTEM | Aug 17, 2010 | Substantially Equivalent |
| K091614 | OSTEOMED FOOT PLATING SYSTEM | Sep 10, 2009 | Substantially Equivalent |