MOD-C
510(k) K242303
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242303 | Date1 Apr 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ODP
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The MOD-C is a cervical intervertebral implant. It is part of a family of devices designed for the treatment of degenerative disc disease of the cervical spine from C2 to T1.
The device is supplied by Orthomod, LLC and has received FDA 510(k) clearance under K-number K242303. It is classified under product code ODP and was reviewed by the Orthopedic advisory committee. The device is intended for use in spinal orthopedic procedures.