510(k) K984209
- Device
- STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
- Applicant
- BIOMET, INC.
- 510(k) number
- K984209
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-02-03
- Date received
- 1998-11-24
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALENE HUFZIGER BINKLEY
- Address
- Airport Industrial Park P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 1221051
- 2245304
- 3003678543
- 3009923578
- 3010068573
- 3013843055
- 9610921
- 1422572
- 3011127597
- 3003541440
- 3005562917
- 8010099
- 3010041511
- 3011295718
- 1020279
- 3004369035
- 3009973699
- 3008729892
- 3010041430
- 3007420745
- 3015173212
- 3022518322
- 3015453963
- 2030624
- 3009959868
- 3014315669
- 3033519208
- 3027339877
- 3007319107
- 3006783837
- 3007289093
- 3014302784
- 3011296511
- 3016237080
- 2249615
- 3004142400
- 3009812190
- 3000170817
- 1724955
- 3014937101
- 3015398319
- 3006215390
- 3022159082
- 1319429
- 3016778139
- 2531477
- 3004549189
- 3004153896
- 2183785
- 3013756169
- 3007738812
- 1526439
- 3011187779
- 3014273424
- 9611281
- 3017980495
- 3003755939
- 1219930
- 3010032903
- 1043653
- 1720929
- 3004016606
- 3016247852
- 1644408
- 3008534770
- 3010673777
- 3012491394
- 3013014058
- 3009158523
- 3005004799
- 3011580264
- 3011354099
- 3004187715
- 1828464
- 1833506
- 1835831
- 3005874553
- 3016759112
- 3013564228
Source Documents#
Other 510(k) Records For Product Code HWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026-05-30 |
| K261241 | TriMed Compression Screws | TriMed, Inc. | 2026-05-14 |
| K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026-05-08 |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | 2026-05-01 |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | 2026-04-17 |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | 2026-04-10 |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2026-04-03 |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | 2026-03-18 |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2026-03-06 |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2025-12-31 |
| K251555 | Ultra™ Compression Screw System | Pace Surgical | 2025-11-06 |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | 2025-10-10 |
| K250536 | MetaFore Small Screw System | Extremity Medical, LLC | 2025-10-08 |
| K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025-10-02 |
| K252019 | CurvaFix Low Profile System | Curvafix, Inc. | 2025-08-29 |
Legacy Summary#
summary
FDA Review#
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