Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
K192018 is the FDA 510(k) clearance record for Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device, a class II device, cleared for Titan Spine, Inc. on under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical). FDA's definition for product code ODP reads: "Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". FDA records list 19 510(k) clearances for Titan Spine, Inc., from to . As of , FDA records show 4 recalls naming K192018.
Clearance record
- Decision date
- Received
- (18 days to decision)
- Product code
- ODP Intervertebral Fusion Device With Bone Graft, Cervical
- Regulation
- 21 CFR 888.3080
- Device class
- Class II
- Review panel
- Orthopedic
- Applicant
- Titan Spine, Inc. 6140 W. Executive Dr., Suite A, Mequon WI
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code ODP
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 3 |
| December 2025 | 2 |
| January 2026 | 5 |
| February 2026 | 1 |
| March 2026 | 2 |
| April 2026 | 4 |
| May 2026 | 2 |
| June 2026 | 0 |
| July 2026 | 3 |
| August 2026 | 2 |
| September 2026 | 0 |
| October 2026 | 0 |
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