Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System
K240830 is the FDA 510(k) clearance record for Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System, a class II device, cleared for Orthofix Medical, Inc. on under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar). FDA's definition for product code MAX reads: "Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". FDA records list one 510(k) clearance for Orthofix Medical, Inc. As of , FDA records show no recalls naming K240830.
Clearance record
- Decision date
- Received
- (86 days to decision)
- Product code
- MAX Intervertebral Fusion Device With Bone Graft, Lumbar
- Regulation
- 21 CFR 888.3080
- Device class
- Class II
- Review panel
- Orthopedic
- Applicant
- Orthofix Medical, Inc. 3541 Plano Pkwy., Lewisville TX
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code MAX
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 1 |
| January 2026 | 2 |
| February 2026 | 3 |
| March 2026 | 0 |
| April 2026 | 1 |
| May 2026 | 5 |
| June 2026 | 1 |
| July 2026 | 4 |
| August 2026 | 1 |
| September 2026 | 0 |
| October 2026 | 0 |
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