PILLAR SA Ti Spacer System (82-XXX)
FDA 510(k) clearance K240749 · decided 2024-05-28
Clearance details
- K-number
- K240749
- Device name
- PILLAR SA Ti Spacer System (82-XXX)
- Applicant
- Orthofix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-03-19
- Decision date
- 2024-05-28
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lewisville, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP recall (Z-2555-2025) | Orthofix U.S. LLC | 2025-09-11 |
| Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, imp recall (Z-1432-2025) | Orthofix U.S. LLC | 2025-03-21 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CervicalStim® (P030034/S017) | Orthofix, Inc. | 2022-06-14 |
| PhysioStim®, SpinalStim® (P850007/S046) | Orthofix, Inc. | 2022-06-14 |
| SpinalStim (P850007/S044) | Orthofix, Inc. | 2020-03-27 |
| CervicalStim (P030034/S015) | Orthofix, Inc. | 2019-10-08 |
| PhysioStim and SpinalStim (P850007/S043) | Orthofix, Inc. | 2019-10-08 |
| SpinalStim (P850007/S042) | Orthofix, Inc. | 2019-07-03 |
| PhysioStim and SpinalStim (P850007/S041) | Orthofix, Inc. | 2019-06-18 |
| CervicalStim (P030034/S014) | Orthofix, Inc. | 2019-06-18 |