ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
FDA 510(k) clearance K101997 · decided 2011-07-12
Clearance details
- K-number
- K101997
- Device name
- ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
- Applicant
- Ellipse Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-15
- Decision date
- 2011-07-12
- Days to decision
- 362 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/I recall (Z-0319-2022) | NuVasive Specialized Orthopedics, Inc. | 2021-12-01 |
| NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRE recall (Z-1349-2021) | Nuvasive Specialized Orthopedics Inc | 2021-04-05 |