AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
FDA 510(k) clearance K100623 · decided 2010-06-09
Clearance details
- K-number
- K100623
- Device name
- AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
- Applicant
- Aesculap Implant Systems
- Decision
- Substantially Equivalent
- Date received
- 2010-03-04
- Decision date
- 2010-06-09
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST recall (Z-2333-2012) | Aesculap Implant Systems LLC | 2012-09-07 |