Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture
FDA 510(k) K042778 · Linvatec Corp.
510(k) numberK042778
Submission
- Device name
- Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- October 6, 2004
- Decision date
- November 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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| K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRMAI · Traditional | 06/22/2009SE |
| K090186 | Conmed Linvatec Paladin, Preloaded with Two #2 Hi-Fi SuturesMAI · Special | 04/10/2009SE |
| K083281 | El Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…GEI · Traditional | 02/25/2009SE |
| K060198 | Micropower Hand Piece : Medium Speed Drill, Saggital Saw, Reciprocating Saw, and…HRX · Special | 05/11/2006SE |
| K060270 | Micropower Hand Piece: Oral Max High Speed DrillDZI · Special | 04/10/2006SE |
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| K050519 | Advanced Turbo Drive SystemGEY · Special | 05/17/2005SE |
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Questions and answers
When was Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture cleared by the FDA?
Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture (K042778) received a 510(k) decision of Substantially Equivalent on November 4, 2004, 29 days after the submission was received.
What is the product code of K042778?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.