Biolok Screw
FDA 510(k) K002070 · Biocomposites, Ltd.
510(k) numberK002070
Submission
- Device name
- Biolok Screw
- Applicant
- Biocomposites, Ltd.
Stoke On Trent, GB - Received
- July 7, 2000
- Decision date
- August 25, 2000
- 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 |
|---|---|---|
| K251680 | Biosteon® ScrewMAI · Traditional | 02/17/2026SE |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerKWL · Traditional | 06/12/2025SE |
| K250521 | NanoBone® SBX Putty ; NanoBone® QDMQV · Traditional | 04/07/2025SE |
| K212721 | Genex Bone Graft SubstituteMQV · Traditional | 02/04/2022SE |
| K141830 | Stimulan Kit, Stimulan Rapid CureMQV · Traditional | 01/23/2015SE |
| K082381 | GenexMQV · Traditional | 11/14/2008SE |
| K082383 | Fortoss VitalLYC · Special | 09/05/2008SE |
| K073341 | Genex PuttyMQV · Traditional | 07/09/2008SE |
| K081428 | Modification to Doubleplay Suture AnchorHWC · Special | 06/20/2008SE |
| K072127 | DominatorHWC · Special | 08/31/2007SE |
Questions and answers
When was Biolok Screw cleared by the FDA?
Biolok Screw (K002070) received a 510(k) decision of Substantially Equivalent on August 25, 2000, 49 days after the submission was received.
What is the product code of K002070?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.