FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Signus Tetris St; Signus Tetris R St
K Number: K241438
·
Decision Sep 11, 2024
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
23
Review Days
113
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Basic Information
- Device Name
- Signus Tetris St; Signus Tetris R St
- K Number
- K241438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Signus Medizintechnik GmbH
- Date Received
- May 21, 2024
- Decision Date
- September 11, 2024
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Signus Medizintechnik GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K243188 | CYLOX® ST | Feb 11, 2025 | Substantially Equivalent |
| K220658 | COSY Cervicothoracic Occipital Rod-Screw System | Nov 18, 2022 | Substantially Equivalent |
| K212755 | SIGNUS SACRONAIL® Transsacral Stabilization System | Mar 10, 2022 | Substantially Equivalent |
| K151704 | Diplomat® Spinal System | Apr 13, 2016 | Substantially Equivalent |
| K141405 | MOBIS II ST SPINAL IMPLANT | Sep 16, 2014 | Substantially Equivalent |
| K123758 | TASMIN R | Jan 14, 2014 | Substantially Equivalent |
| K131372 | MOBIS II | Jul 2, 2013 | Substantially Equivalent |
| K122317 | TETRIS II | Aug 29, 2012 | Substantially Equivalent |
| K111792 | MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI | Mar 5, 2012 | Substantially Equivalent |
| K090387 | KAINOS+ | Sep 28, 2009 | Substantially Equivalent |