Parcus Ppek CF Interference Screw
FDA 510(k) K091093 · Parcus Medical, LLC
510(k) numberK091093
Submission
- Device name
- Parcus Ppek CF Interference Screw
- Applicant
- Parcus Medical, LLC
Sturgeon Bay, WI, US - Received
- April 16, 2009
- Decision date
- September 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
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| K232513 | X-Twist Biocomposite Suture AnchorMAI · Special | 09/18/2023SE |
| K221502 | Parcus Synd-EZ SSMBI · Traditional | 07/26/2022SE |
| K221135 | X-Twist PEEK Suture AnchorMBI · Special | 05/19/2022SE |
| K212739 | ActiFlipMBI · Traditional | 10/06/2021SE |
| K202662 | Parcus Titanium Interference ScrewsMBI · Traditional | 02/22/2021SE |
| K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…MBI · Traditional | 10/28/2020SE |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsMBI · Traditional | 07/23/2020SE |
| K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorMBI · Special | 01/23/2020SE |
| K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipMBI · Traditional | 01/16/2020SE |
| K192964 | Parcus Synd-EZ SSMBI · Special | 11/22/2019SE |
Questions and answers
When was Parcus Ppek CF Interference Screw cleared by the FDA?
Parcus Ppek CF Interference Screw (K091093) received a 510(k) decision of Substantially Equivalent on September 30, 2009, 167 days after the submission was received.
What is the product code of K091093?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.