FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
InterOss
K Number: K151209
·
Decision Nov 6, 2015
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
39
Applicant Total
3
Review Days
184
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
- InterOss
- K Number
- K151209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sigmagraft, Inc.
- Date Received
- May 6, 2015
- Decision Date
- November 6, 2015
- Product Code
- NPM
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| NPM | Bone Grafting Material, Animal Source | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NPM), ordered by most recent decision date.
BOSS
FDA 510(k)
FDA Class 2
·Dental
Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®
FDA 510(k)
FDA Class 2
·Dental
SwissGraft X
FDA 510(k)
FDA Class 2
·Dental
Geistlich Bio-Flow®
FDA 510(k)
FDA Class 2
·Dental
Xenograft Bovine Bone Particulate
FDA 510(k)
FDA Class 2
·Dental
THE Graft Collagen
FDA 510(k)
FDA Class 2
·Dental