FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CITRELOCK® DUO
K Number: K232592
·
Decision Sep 20, 2023
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
6
Review Days
26
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Basic Information
- Device Name
- CITRELOCK® DUO
- K Number
- K232592
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acuitive Technologies, Inc.
- Date Received
- August 25, 2023
- Decision Date
- September 20, 2023
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, 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 |
| K221468 | Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants | Feb 14, 2023 | Substantially Equivalent |
| K220833 | Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL | Nov 4, 2022 | Substantially Equivalent |
| K210239 | CITRESPLINE and CITRELOCK ACL Implants | Feb 24, 2021 | Substantially Equivalent |
| K203334 | The Citrefix Knotless Suture Anchor | Feb 5, 2021 | Substantially Equivalent |