Parcus Medical, L.L.C.
Sarasota, FL, US
PARCUS MEDICAL , L.L.C. appears in FDA device records in Sarasota, FL. FDA records list 31 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 31 510(k) clearances for Parcus Medical, L.L.C. between 2009 and 2023. The busiest year on record is 2019, with 6. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 5 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2019 | 6 |
| 2020 | 4 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232513 | X-Twist Biocomposite Suture Anchor | MAI | Substantially Equivalent | |
| K221502 | Parcus Synd-EZ SS | MBI | Substantially Equivalent | |
| K221135 | X-Twist PEEK Suture Anchor | MBI | Substantially Equivalent | |
| K212739 | ActiFlip | MBI | Substantially Equivalent | |
| K202662 | Parcus Titanium Interference Screws | MBI | Substantially Equivalent | |
| K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip | MBI | Substantially Equivalent | |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | MBI | Substantially Equivalent | |
| K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | MBI | Substantially Equivalent | |
| K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | MBI | Substantially Equivalent | |
| K192964 | Parcus Synd-EZ SS | MBI | Substantially Equivalent | |
| K192824 | Parcus Knotless AP Suture Anchors | MAI | Substantially Equivalent | |
| K191783 | Parcus Synd-EZ Ti | MBI | Substantially Equivalent | |
| K190375 | Parcus ATLAS | MBI | Substantially Equivalent | |
| K183501 | Parcus Twist AP Suture Anchors | MAI | Substantially Equivalent | |
| K183331 | Parcus GFS BTB | MBI | Substantially Equivalent | |
| K170877 | Parcus SLiK Fix Screw | MBI | Substantially Equivalent | |
| K170327 | Parcus SLiK Anchors | MBI | Substantially Equivalent | |
| K162198 | GFS Ultimate | MBI | Substantially Equivalent | |
| K152711 | Parcus GFS Naked | MBI | Substantially Equivalent | |
| K133757 | GFS II STANDARD, GFS II LARGE, GFS MIMI | MBI | Substantially Equivalent | |
| K122805 | PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR | MBI | Substantially Equivalent | |
| K120942 | PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC | MBI | Substantially Equivalent | |
| K113730 | PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS | MBI | Substantially Equivalent | |
| K111000 | PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR | HWC | Substantially Equivalent | |
| K102326 | PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR | HWC | Substantially Equivalent | |
| K102162 | PARCUS PEEK CF PUSH-IN SUTURE ANCHOR | HWC | Substantially Equivalent | |
| K091094 | PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 | MBI | Substantially Equivalent | |
| K091093 | PARCUS PPEK CF INTERFERENCE SCREW | HWC | Substantially Equivalent | |
| K090923 | PARCUS GRAFT FIXATION SYSTEM | MBI | Substantially Equivalent | |
| K090075 | PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 | MBI | Substantially Equivalent | |
| K083619 | PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 | HWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007319107 | 3007319107 | PARCUS MEDICAL , L.L.C. | 6423 Parkland Dr, Sarasota, FL 34243 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- HWJAwl
- HTWBit, Drill
- KQZComponent, Traction, Non-Invasive
- HTEElevator
- HWBExtractor
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- FZXGuide, Surgical, Instrument
- MDMInstrument, Manual, Surgical, General Use
- LXHOrthopedic Manual Surgical Instrument
- HWQPasser
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- HWDStarter, Bone Screw
- HRTStripper, Surgical
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- HWXTap, Bone
- HTNWasher, Bolt Nut
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain