FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL
K Number: K220833
·
Decision Nov 4, 2022
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
6
Review Days
227
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Basic Information
- Device Name
- Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL
- K Number
- K220833
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acuitive Technologies, Inc.
- Date Received
- March 22, 2022
- Decision Date
- November 4, 2022
- Product Code
- MAI
- 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 |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Acuitive Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240450 | Citrepore | Nov 6, 2024 | Substantially Equivalent |
| K232592 | CITRELOCK® DUO | Sep 20, 2023 | Substantially Equivalent |
| K221468 | Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants | Feb 14, 2023 | Substantially Equivalent |
| K210239 | CITRESPLINE and CITRELOCK ACL Implants | Feb 24, 2021 | Substantially Equivalent |
| K203334 | The Citrefix Knotless Suture Anchor | Feb 5, 2021 | Substantially Equivalent |