FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
Pitkar External Fixation System - Rail Mechanism
K Number: K200518
·
Decision Jul 29, 2020
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
5
Review Days
149
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Basic Information
- Device Name
- Pitkar External Fixation System - Rail Mechanism
- K Number
- K200518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S.H.Pitkar Orthotools Pvt. , Ltd.
- Date Received
- March 2, 2020
- Decision Date
- July 29, 2020
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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Other Clearances by S.H.Pitkar Orthotools Pvt. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K240233 | Pitkar Spinal Pedicle Screw System | Sep 9, 2024 | Substantially Equivalent |
| K200728 | Pitkar DeftFix System | Oct 6, 2020 | Substantially Equivalent |
| K192619 | Pitkar Locked Plating System | Feb 27, 2020 | Substantially Equivalent |
| K190486 | Pitkar External Fixation System | Oct 16, 2019 | Substantially Equivalent |