Citrepore— 510(k) K240450
Substantially EquivalentAcuitive Technologies, Inc.
FDA 510(k) clearance K240450 for Citrepore, Substantially Equivalent on 2024-11-06. Applicant: Acuitive Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Acuitive Technologies, Inc.
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alendale, NJ, US
Recent devices under product code MQV
view allMore clearances from Acuitive Technologies, Inc.
view all- K232592 — CITRELOCK® DUO
- K221468 — Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants
- K220833 — Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL
- K210239 — CITRESPLINE and CITRELOCK ACL Implants
- K203334 — The Citrefix Knotless Suture Anchor
Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.