Impulse AM Interbody Fusion System
510(k) K210090
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210090 | Date30 Aug 2021 | 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- Withdrawn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
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Impulse AM Interbody Fusion System is an interbody fusion device designed for lumbar spine procedures, including posterior and transforaminal lumbar fusion. Constructed from DeGen Medical’s proprietary Titanium PURI-TI™ with a diamond lattice structure, it is intended for use in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis at contiguous lumbar levels (L2–S1).
This system is supplied in various dimensions, including different lengths, widths, heights, and endplate curvatures (neutral, lordotic, and anatomic). It is a reusable device, not sterile at time of shipment, and requires surgical preparation prior to use. The device holds an FDA 510(k) clearance under the Traditional review pathway, classified under product code MAX and advisory committee OR.