ORTHOFIX MODULSYSTEM
FDA 510(k) clearance K955848 · decided 1996-03-20
Clearance details
- K-number
- K955848
- Device name
- ORTHOFIX MODULSYSTEM
- Applicant
- Orthofix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-27
- Decision date
- 1996-03-20
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- JDW
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Orthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600, manufactured by Orth recall (Z-1434-2010) | Orthofix Srl | 2010-04-28 |
| Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL, recall (Z-1435-2010) | Orthofix Srl | 2010-04-28 |
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 |