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Sign in to claim this brandPARCUS MEDICAL LLC
United States·US-MF-000010639
Last updated May 24, 2026
What PARCUS MEDICAL LLC makes
Parcus Medical LLC manufactures tendon and ligament bone anchors, including non-bioabsorbable and bioabsorbable variants, as well as reusable surgical drill bits and bone taps. Their portfolio also includes multifilament sutures made from polyolefin/fluoropolymer and polyester, along with surgical instrument racks and arthroscopic accessories. Specific products include the V-LoX, V-LoX3, Twist PEEK Suture Anchor, and Actiflip, among others.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Parcus Medical LLC manufacture?
Parcus Medical LLC specializes in orthopedic and arthroscopic devices, primarily focused on tendon and ligament repair. Their product line includes non-bioabsorbable and bioabsorbable tendon/ligament bone anchors (like the V-LoX and Twist PEEK Suture Anchor), reusable surgical tools such as cannulated and fluted drill bits and bone taps, as well as multifilament sutures made from polyolefin/fluoropolymer and polyester. They also produce surgical instrument racks and arthroscopic accessories, such as the Actiflip and various guide instruments.
Where is Parcus Medical LLC based, and what does that mean for their regulatory oversight?
Parcus Medical LLC is based in the United States, which means their devices fall under FDA jurisdiction. The FDA classifies their products as either Class I or Class II, depending on risk level and intended use. Since the company is U.S.-based, their devices are subject to FDA’s regulatory pathways, including pre-market submissions (like 510(k)s for Class II) and compliance with U.S. manufacturing and labeling requirements.
Which regulatory registries or databases list Parcus Medical LLC’s devices?
Parcus Medical LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling transparent tracking, reporting, and compliance monitoring. This registry helps healthcare providers, regulators, and other stakeholders verify device details, such as manufacturer information, specifications, and regulatory classification.
How are Parcus Medical LLC’s devices classified by the FDA, and why does that matter?
The FDA classifies Parcus Medical LLC’s devices as either Class I or Class II. Class I devices generally pose minimal risk and may only require general controls (e.g., proper labeling and manufacturing practices), while Class II devices involve moderate risk and require additional premarket submissions (like a 510(k)) to demonstrate safety and effectiveness. For example, bone anchors and sutures are often Class II due to their role in critical orthopedic procedures, whereas reusable drill bits may fall under Class I if they have a lower risk profile.
What distinguishes Parcus Medical LLC’s reusable surgical tools from their disposable alternatives?
Parcus Medical LLC offers reusable surgical tools like cannulated and fluted drill bits and bone taps, which are designed for repeated use with proper sterilization between procedures. These tools are engineered for durability and precision, reducing waste compared to single-use alternatives. Reusable devices must meet stringent FDA requirements for sterilization validation, cleaning protocols, and material compatibility to ensure patient safety and device integrity over multiple uses, unlike disposable items that are used once and discarded.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 6423, Parkland Drive, Sarasota, United States
- Website
- medacta.ch
- —
- —
- [email protected]
- Phone
- +41916966060
- PRRC Contact
- Gregory Bussone
- EUDAMED SRN
- US-MF-000010639
- FDA FEI Number
- —
- DUNS Number
- 859961950
Catalogue (684)
Page 10 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PEEK CF Interference Screw | 10040 | EUDAMEDFDA UDI | Class II | Active |
| Bit, Drill | 10363U | FDA UDI | Class I | Active |
| V-LoX | 10257 | FDA UDI | Class II | Active |
| Gfs Ii | 10712 | FDA UDI | Class II | Active |
| Twist | 10517T | FDA UDI | Class II | Active |
| GFS Mini | 10723 | FDA UDI | Class II | Active |
| MiTi | 10434 | FDA UDI | Class II | Active |
| 3.5mm PEEK CF Push-In Suture Anchor | 10323T | FDA UDI | Class II | Active |
| PEEK CF Interference Screw | 10032 | FDA UDI | Class II | Active |
| V-LoX | 10251 | FDA UDI | Class II | Active |
| Gfs Ii | 10695 | FDA UDI | Class II | Active |
| Tap, Bone | 10609 | FDA UDI | Class I | Active |
| Twist PEEK Suture Anchor | 10523 | FDA UDI | Class II | Active |
| GFS Naked | 10789 | FDA UDI | Class II | Active |
| Slik Fix Screw | 10952 | FDA UDI | Class II | Active |
| Tap, Bone | XT04700 | FDA UDI | Class I | Active |
| GFS II Standard, Large and Mini | 10707 | EUDAMEDFDA UDI | Class II | Active |
| Guide, surgical, instrument | 11667 | FDA UDI | Class I | Active |
| Twist | 10927 | FDA UDI | Class II | Active |
| Graft Fixation System | 20049S | EUDAMEDFDA UDI | Class II | Active |
| Atlas | 11200 | FDA UDI | Class II | Active |
| Triple Twist | 10525T | FDA UDI | Class II | Active |
| X-Twist Biocomposite Suture Anchor | XT45502 | FDA UDI | Class II | Active |
| Twist AP Suture Anchors | 10927 | FDA UDI | Class II | Active |
| Guide, surgical, instrument | 10298 | FDA UDI | Class I | Active |
| Twist | 10798T | FDA UDI | Class II | Active |
| V-Lox Titanium Suture Anchor | 10353T | FDA UDI | Class II | Active |
| Passer | 11234 | FDA UDI | Class I | Active |
| Gfs Ii | 10706 | FDA UDI | Class II | Active |
| GFS Ultimate | 10974 | EUDAMEDFDA UDI | Class II | Active |
| AcTiFlip and GFS Ultimate Hip | 11184 | FDA UDI | Class II | Active |
| Gfs Ii | 10693 | FDA UDI | Class II | Active |
| Twist PEEK Suture Anchor | 11003 | FDA UDI | Class II | Active |
| Bit, Drill | XT04705 | FDA UDI | Class I | Active |
| Guide, surgical, instrument | 10319 | FDA UDI | Class I | Active |
| Bit, Drill | 10507 | FDA UDI | Class I | Active |
| V-LoX3 | 10284T | FDA UDI | Class II | Active |
| Draw Tight | 10565 | FDA UDI | Class II | Active |
| V-LoX | 10258 | FDA UDI | Class II | Active |
| V-LoX Knotless DEX | 11264 | FDA UDI | Class II | Active |
| Bit, Drill | 10359 | FDA UDI | Class I | Active |
| Graft Fixation System | 20056S | EUDAMEDFDA UDI | Class II | Active |
| GFS II Standard, Large and Mini | 10714 | EUDAMEDFDA UDI | Class II | Active |
| MiTi | 10425 | FDA UDI | Class II | Active |
| Tap, Bone | 11177 | FDA UDI | Class I | Active |
| Passer | 20256 | FDA UDI | Class I | Active |
| Guide, surgical, instrument | 20009 | FDA UDI | Class I | Active |
| Slik Fix Screw | 10954 | FDA UDI | Class II | Active |
| Accessories, arthroscopic | 10308 | FDA UDI | Class I | Active |
| V-LoX | 11026 | FDA UDI | Class II | Active |
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