CONTOURS LAPIDUS PLATING SYSTEM
FDA 510(k) clearance K102201 · decided 2010-12-15
Clearance details
- K-number
- K102201
- Device name
- CONTOURS LAPIDUS PLATING SYSTEM
- Applicant
- Orthofix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-08-04
- Decision date
- 2010-12-15
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mckinney, 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
No recalls on record reference this clearance.
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 |