FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LANX CERVICAL SA
K Number: K112388
·
Decision Dec 16, 2011
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
23
Review Days
120
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
- LANX CERVICAL SA
- K Number
- K112388
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lanx, Inc.
- Date Received
- August 18, 2011
- Decision Date
- December 16, 2011
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVE), ordered by most recent decision date.
CONDUIT ZERO-P VA Secured Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
NeckTune 3D SA Cervical Cage
FDA 510(k)
FDA Class 2
·Orthopedic
SABER-C System
FDA 510(k)
FDA Class 2
·Orthopedic
SAGI Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Uni-C Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
E3D-C Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Lanx, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K131547 | LANX FUSION SYSTEM | Jul 12, 2013 | Substantially Equivalent |
| K131156 | LANX SPINAL FIXATION SYSTEM | May 24, 2013 | Substantially Equivalent |
| K123767 | LANX FUSION SYSTEM- SA | Mar 18, 2013 | Substantially Equivalent |
| K121316 | LANX SPINAL FIZATION SYSTEM | Sep 10, 2012 | Substantially Equivalent |
| K122145 | LANX SPINAL FIXATION SYSTEM | Aug 17, 2012 | Substantially Equivalent |
| K121940 | LANX SPINAL FIXATION SYSTEM | Aug 2, 2012 | Substantially Equivalent |
| K113434 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | Dec 19, 2011 | Substantially Equivalent |
| K103091 | LANX SPINAL FIXATION SYSTEM | Apr 15, 2011 | Substantially Equivalent |
| K103237 | LANX SPINAL SYSTEM | Mar 25, 2011 | Substantially Equivalent |
| K103666 | LANX LATERAL | Mar 23, 2011 | Substantially Equivalent |