FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
K Number: K111176
·
Decision Aug 15, 2011
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
29
Review Days
110
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
- OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
- K Number
- K111176
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed LP
- Date Received
- April 27, 2011
- Decision Date
- August 15, 2011
- Product Code
- GWO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWO), ordered by most recent decision date.
TECHFIT Patient-Specific Cranial System
FDA 510(k)
FDA Class 2
·Neurology
Fusion Craniofacial Implant; Fusion Skull Implant
FDA 510(k)
FDA Class 2
·Neurology
VSP PEEK Cranial Implant
FDA 510(k)
FDA Class 2
·Neurology
MCI-Neuro Fixation System
FDA 510(k)
FDA Class 2
·Neurology
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
FDA 510(k)
FDA Class 2
·Neurology
Stryker PEEK Customized Cranial Implant Kit
FDA 510(k)
FDA Class 2
·Neurology
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 |
| K102438 | PRIMALOK FACET FIXATION SYSTEM | Sep 30, 2010 | Substantially Equivalent |
| K100354 | PRIMAL OK INTERSPINOUS FUSION SYSTEM | Aug 17, 2010 | Substantially Equivalent |
| K091614 | OSTEOMED FOOT PLATING SYSTEM | Sep 10, 2009 | Substantially Equivalent |