FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERFORM INTERBODY CAGE SYSTEM
K Number: K131082
·
Decision Aug 26, 2013
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
6
Review Days
130
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Basic Information
- Device Name
- INTERFORM INTERBODY CAGE SYSTEM
- K Number
- K131082
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Next Orthosurgical
- Date Received
- April 18, 2013
- Decision Date
- August 26, 2013
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Next Orthosurgical
| K Number | Device Name | ||
|---|---|---|---|
| K242509 | HAnano InterFuse(R) Modular Interbody | Sep 19, 2024 | Substantially Equivalent |
| K190981 | NEX-D2 Posterior Fixation System | Jan 15, 2020 | Substantially Equivalent |
| K161608 | InterForm Cervical Interbody Cage System | Sep 30, 2016 | Substantially Equivalent |
| K161499 | VertiForm Posterior Fixation System | Jul 29, 2016 | Substantially Equivalent |
| K141291 | VERTIFORM POSTERIOR FIXATION SYSTEM | Aug 26, 2014 | Substantially Equivalent |