The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Xsert Lumbar Expandable Interbody System.
| Device ID | K160959 |
| 510k Number | K160959 |
| Device Name: | Xsert Lumbar Expandable Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. Miamisburg, OH 45342 |
| Contact | Kriss Anderson |
| Correspondent | Kriss Anderson X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. Miamisburg, OH 45342 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-05 |
| Decision Date | 2016-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M697X092121032STR0 | K160959 | 000 |
| M697X092091026STR0 | K160959 | 000 |
| M697X0920910265STR0 | K160959 | 000 |
| M697X09209102650 | K160959 | 000 |
| M697X0920910260 | K160959 | 000 |
| M697X092091024STR0 | K160959 | 000 |
| M697X0920910245STR0 | K160959 | 000 |
| M697X09209102450 | K160959 | 000 |
| M697X0920910240 | K160959 | 000 |
| M697X092071032STR0 | K160959 | 000 |
| M697X0920710320 | K160959 | 000 |
| M697X092071026STR0 | K160959 | 000 |
| M697X0920710260 | K160959 | 000 |
| M697X092071024STR0 | K160959 | 000 |
| M697X0920910320 | K160959 | 000 |
| M697X092091032STR0 | K160959 | 000 |
| M697X0921210320 | K160959 | 000 |
| M697X092121026STR0 | K160959 | 000 |
| M697X0921210265STR0 | K160959 | 000 |
| M697X09212102650 | K160959 | 000 |
| M697X09212102610STR0 | K160959 | 000 |
| M697X092121026100 | K160959 | 000 |
| M697X0921210260 | K160959 | 000 |
| M697X092121024STR0 | K160959 | 000 |
| M697X0921210245STR0 | K160959 | 000 |
| M697X09212102450 | K160959 | 000 |
| M697X09212102410STR0 | K160959 | 000 |
| M697X092121024100 | K160959 | 000 |
| M697X0921210240 | K160959 | 000 |
| M697X0920710240 | K160959 | 000 |