510(k) K003816
- Device
- ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM
- Applicant
- ARTHREX, INC.
- 510(k) number
- K003816
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-03-09
- Date received
- 2000-12-11
- 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
- VERNON C BROWN
- Address
- 2885 S. Horseshoe Dr. Naples FL US 34104 34104
FDA Registration Numbers#
- 3004369035
- 1935627
- 3006849754
- 3014967149
- 3035373797
- 1319639
- 3003236702
- 3017565094
- 3008812560
- 3004049923
- 3012086398
- 1043534
- 3017191784
- 3010331645
- 3009116370
- 3007993775
- 3027339877
- 3015724777
- 3009882462
- 3006801265
- 9680619
- 3015259876
- 3003898228
- 3019269298
- 3010509633
- 3038776593
- 2320767
- 3014262693
- 1835572
- 3016759112
- 3013700547
- 2090040
- 3014483751
- 3012724179
- 3024021261
- 3006108336
- 3005180920
- 3011388423
- 1424434
- 3016438694
- 3043026734
- 3030400539
- 3030271054
- 3010440433
- 3007922509
- 3016660811
- 3011296511
- 3012711663
- 9611827
- 3012755988
- 3010120135
- 3003678543
- 3003249380
- 3008868758
- 8031020
- 3007766601
- 1828288
- 3026311512
- 9610921
- 1834331
- 3034525
- 3010041499
- 1057425
- 1222274
- 3043543260
- 3043620689
- 3019455
- 1226146
- 3009996260
- 3010370880
- 2133928
- 3016084569
- 3004431266
- 3030183061
- 3002719998
- 3013846070
- 3012130008
- 1226183
- 3007593722
- 3004187715
Source Documents#
Other 510(k) Records For Product Code HWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261961 | Ntegrate Threaded Nail System | Nvision Biomedical Technologies | 2026-10-14 |
| K263116 | OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts | OsteoCentric Technologies | 2026-10-02 |
| K262975 | Arthrex Beaming System | Arthrex, Inc. | 2026-09-25 |
| K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026-09-23 |
| K254280 | F.A.S.T Screw | Steps Ortho | 2026-09-21 |
| K261057 | ActivaScrew™ Cannulated COM | Bioretec, Ltd. | 2026-09-04 |
| K260106 | OsteoCoil™ GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | 2026-08-24 |
| K262344 | Large Compression Screws | TriMed, Inc. | 2026-08-12 |
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 |
| K262075 | Lapidus Screw Kit | Relja Innovations, LLC | 2026-07-22 |
| K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2026-06-25 |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | 2026-06-05 |
| 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 |
Legacy Summary#
summary
FDA Review#
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