Twist-Off (TM) Screw
FDA 510(k) K971069 · Landos, Inc.
510(k) numberK971069
Submission
- Device name
- Twist-Off (TM) Screw
- Applicant
- Landos, Inc.
Malvern, PA, US - Received
- March 24, 1997
- Decision date
- July 9, 1997
- 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 |
|---|---|---|
| K964226 | Memory Staple (20 Sizes Available)JDR · Traditional | 08/05/1997SE |
| K971070 | Scarf Thread-Head (TM) Head ScrewHWC · Traditional | 07/09/1997SE |
| K971068 | 34MM Scarf Thread-Head(Tm) ScrewHWC · Traditional | 07/09/1997SE |
| K961732 | KarMEH · Traditional | 07/08/1997SE |
| K970846 | 22.2/+4MM Co CR & Zirconia Femoral HeadLZO · Traditional | 06/05/1997SN |
| K953111 | CorailLZO · Traditional | 12/27/1996SE |
| K962233 | Twist-Off ScrewHWC · Traditional | 10/03/1996SE |
| K962236 | Scarf Thread-Head ScrewHWC · Traditional | 09/20/1996SE |
| K960642 | Nancy NailHTY · Traditional | 05/17/1996SE |
| K943727 | Biostop G Bone Cement RestrictorLZN · Traditional | 05/11/1995SE |
Questions and answers
When was Twist-Off (TM) Screw cleared by the FDA?
Twist-Off (TM) Screw (K971069) received a 510(k) decision of Substantially Equivalent on July 9, 1997, 107 days after the submission was received.
What is the product code of K971069?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.