Bioscrew Xtralok, 8X35MM & 8X40MM Violet
FDA 510(k) K050497 · Linvatec Corp.
510(k) numberK050497
Submission
- Device name
- Bioscrew Xtralok, 8X35MM & 8X40MM Violet
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- February 28, 2005
- Decision date
- March 25, 2005
- 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
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K092998 | Conmed Linvatec Intercept ImplantMBI · Traditional | 12/23/2009SE |
| K091549 | Conmed Linvatec Soft Tissue to Bone SystemMBI · Special | 06/23/2009SE |
| 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 |
| K060260 | Micropower Hand Piece High Speed DrillHBC · Special | 04/10/2006SE |
| K050519 | Advanced Turbo Drive SystemGEY · Special | 05/17/2005SE |
| K050227 | Threvo Suture Anchor with Disposable DriverMBI · Special | 03/02/2005SE |
Questions and answers
When was Bioscrew Xtralok, 8X35MM & 8X40MM Violet cleared by the FDA?
Bioscrew Xtralok, 8X35MM & 8X40MM Violet (K050497) received a 510(k) decision of Substantially Equivalent on March 25, 2005, 25 days after the submission was received.
What is the product code of K050497?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.