FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Juliet® Ti LL Lumbar Interbody Device
K Number: K241321
·
Decision Jul 18, 2024
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
11
Review Days
69
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Basic Information
- Device Name
- Juliet® Ti LL Lumbar Interbody Device
- K Number
- K241321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spineart SA
- Date Received
- May 10, 2024
- Decision Date
- July 18, 2024
- Product Code
- OVD
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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| K242890 | SPINEART Navigation Instrument System | Mar 7, 2025 | Substantially Equivalent |
| K242589 | Scarlet® AL-T | Oct 23, 2024 | Substantially Equivalent |
| K241644 | SPINEART Navigation Instrument System | Aug 7, 2024 | Substantially Equivalent |
| K240699 | SCARLET® AC-Ti | May 10, 2024 | Substantially Equivalent |
| K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Oct 25, 2023 | Substantially Equivalent |
| K230583 | Tryptik Ti | Mar 22, 2023 | Substantially Equivalent |
| K183630 | SPINEART Navigation Instrument System | Jun 10, 2019 | Substantially Equivalent |