FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
TELIGEN System
K Number: K213978
·
Decision Oct 18, 2022
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
96
Review Days
302
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TELIGEN System
- K Number
- K213978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medos International SARL
- Date Received
- December 20, 2021
- Decision Date
- October 18, 2022
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRX), ordered by most recent decision date.
Digital ClarusScope System and Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom DS Decompression System
FDA 510(k)
FDA Class 2
·Orthopedic
VantageTM Lumbar Decompression Kit
FDA 510(k)
FDA Class 2
·Orthopedic
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
FDA 510(k)
FDA Class 2
·Orthopedic
PUREVUE FMS
FDA 510(k)
FDA Class 2
·Orthopedic
Articulator Arthroscopic Bur
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Medos International SARL
| K Number | Device Name | ||
|---|---|---|---|
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | May 26, 2026 | Substantially Equivalent |
| K260240 | SYMPHONY Navigation Ready Instruments | Mar 27, 2026 | Substantially Equivalent |
| K253249 | TriALTIS Spine System | Oct 21, 2025 | Substantially Equivalent |
| K243249 | TriALTIS Spine System | Jan 17, 2025 | Substantially Equivalent |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Sep 16, 2024 | Substantially Equivalent |
| K242042 | TriALTIS Spine System | Sep 9, 2024 | Substantially Equivalent |
| K233684 | TriALTIS Spine System | Dec 12, 2023 | Substantially Equivalent |
| K233366 | SYMPHONY OCT System | Nov 9, 2023 | Substantially Equivalent |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | Oct 6, 2023 | Substantially Equivalent |
| K231479 | TriALTIS Spine System | Sep 22, 2023 | Substantially Equivalent |