FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
True Spinal Fixation System
K Number: K171559
·
Decision Jul 24, 2017
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
7
Review Days
55
Basic Information
- Device Name
- True Spinal Fixation System
- K Number
- K171559
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Innovative Surgical Designs, Inc.
- Date Received
- May 30, 2017
- Decision Date
- July 24, 2017
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by Innovative Surgical Designs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220297 | True Tulip, True M.I.S. | Sep 16, 2022 | Substantially Equivalent |
| K212627 | True Tulip, True M.I.S. | Feb 18, 2022 | Substantially Equivalent |
| K210816 | True Tulip, True M.I.S. | May 18, 2021 | Substantially Equivalent |
| K201780 | True Tulip System, True M.I.S. System | Jul 22, 2020 | Substantially Equivalent |
| K181584 | Redi-Spine | Aug 10, 2018 | Substantially Equivalent |
| K170710 | True Spinal Fixation System | Jul 14, 2017 | Substantially Equivalent |