FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
TDM Lumbar Interbody Fusion Cage System
K Number: K221844
·
Decision Aug 17, 2022
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
11
Review Days
54
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Basic Information
- Device Name
- TDM Lumbar Interbody Fusion Cage System
- K Number
- K221844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tdm Co., Ltd.
- Date Received
- June 24, 2022
- Decision Date
- August 17, 2022
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAX), ordered by most recent decision date.
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aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
FDA 510(k)
FDA Class 2
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Other Clearances by Tdm Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241128 | TDM Plate and Screw System | Dec 5, 2024 | Substantially Equivalent |
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| K240423 | TDM Anterior Cervical Plate System | Apr 8, 2024 | Substantially Equivalent |
| K232115 | TDM Large Bone Plate and Screw System | Apr 5, 2024 | Substantially Equivalent |
| K231860 | TDM Screw System | Jan 18, 2024 | Substantially Equivalent |
| K220285 | PINE Pedicle Screw System | May 19, 2022 | Substantially Equivalent |
| K191057 | Park's Pectus System | Mar 19, 2020 | Substantially Equivalent |
| K190391 | TDM Plate and Screw Systems | Nov 15, 2019 | Substantially Equivalent |
| K190830 | TDM Screw Systems | Sep 13, 2019 | Substantially Equivalent |
| K171808 | TDM Plate and Screw System | Mar 15, 2018 | Substantially Equivalent |