Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw, Short Thread, Stainless Steel Ped
FDA 510(k) K984209 · Biomet, Inc.
510(k) numberK984209
Submission
- Device name
- Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw, Short Thread, Stainless Steel Ped
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- November 24, 1998
- Decision date
- February 3, 1999
- 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 |
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| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | 02/07/2022SE |
| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | 12/10/2021SE |
| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
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Questions and answers
When was Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw, Short Thread, Stainless Steel Ped cleared by the FDA?
Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw, Short Thread, Stainless Steel Ped (K984209) received a 510(k) decision of Substantially Equivalent on February 3, 1999, 71 days after the submission was received.
What is the product code of K984209?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.