510(k) K011719
- Device
- PLUS CANCELLOUS BONE SCREWS
- Applicant
- PLUS ORTHOPEDICS
- 510(k) number
- K011719
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-02
- Date received
- 2001-06-04
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HARTMUT LOCH, RAC
- Address
- 6055 Lusk Blvd. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3003541440
- 1834379
- 3004142400
- 3027339877
- 3015539532
- 3015212339
- 3007740680
- 3012599928
- 3017210488
- 3004016606
- 1720929
- 3014763043
- 3017565094
- 1226183
- 3009871135
- 3014129047
- 3010375065
- 3006783837
- 3005004799
- 3010173425
- 3005983700
- 3022142628
- 2032521
- 3004431266
- 2031093
- 3008696586
- 3009337401
- 3012711663
- 3009423112
- 2031009
- 3030400539
- 3010123256
- 3006498370
- 3012249461
- 2090040
- 3014522470
- 3008749819
- 2183785
- 3011580264
- 3031800723
- 3006946279
- 3009631939
- 3009381600
- 2530808
- 3008132398
- 3005180920
- 3000327445
- 3009513193
- 3015399803
- 2648623
- 2249529
- 3031240334
- 3043543260
- 3007922509
- 3010462278
- 3030412764
- 3014314623
- 3010120326
- 3008650117
- 3013756169
- 2648666
- 3010049501
- 3009149199
- 3010032903
- 3008668801
- 3035373797
- 1221053
- 2531195
- 8031020
- 3007109793
- 3021393544
- 3017521423
- 3004993707
- 3005596372
- 2133928
- 2024024
- 3012724179
- 1835251
- 3011301313
Source Documents#
Other 510(k) Records For Product Code HWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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