510(k) K201379
- Device
- Artemis Proximal Femoral Nail System
- Applicant
- GLW, Inc.
- 510(k) number
- K201379
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-19
- Date received
- 2020-05-26
- Regulation
- 888.3020
- Classification name
- Rod, Fixation, Intramedullary And Accessories
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Arundhati Radhakrishnan
- Address
- 300 Sylvan Ave. Englewood Cliff NJ US 07632 07632
FDA Registration Numbers#
- 3000327445
- 2249615
- 3012392319
- 1835251
- 3013176080
- 3008951116
- 3011127597
- 3008599979
- 3001239363
- 3006460162
- 3010097171
- 3020155054
- 1834331
- 3010220595
- 3010047454
- 3010131578
- 3006849754
- 2029275
- 3005290844
- 3010462278
- 3007539489
- 3019269298
- 3010057495
- 3008514120
- 3005061536
- 1835831
- 3010386387
- 3004635447
- 3004748528
- 3011388423
- 3014257776
- 3014315669
- 3016851379
- 3010120326
- 1833920
- 1643817
- 3017435639
- 3009532798
- 3007344102
- 3009144915
- 1450662
- 3006128100
- 3031261833
- 3015183635
- 3010470577
- 3010370500
- 1833986
- 2032098
- 3004153896
- 3003935342
- 3009158523
- 3009998573
- 9615128
- 3009996260
- 3025141
- 2031966
- 3007125392
- 9710312
- 3016438694
- 1722511
- 2133928
- 1825034
- 3003387384
- 9610726
- 3010606097
- 3006742481
- 1935627
- 3004450489
- 1424434
- 3006783837
- 3004049923
- 1000517406
- 3015216945
- 9681465
- 3010370880
- 3016261131
- 1828464
- 3008749819
- 3006179046
Source Documents#
Other 510(k) Records For Product Code HSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026-06-29 |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. | 2026-06-18 |
| K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | 2026-06-18 |
| K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-17 |
| K253046 | HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-16 |
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl | 2026-05-19 |
| K253991 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | 2026-05-08 |
| K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | 2026-04-24 |
| K252016 | Arthrex Humeral Nails | Arthrex, Inc. | 2026-03-20 |
| K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | 2026-03-18 |
| K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | 2026-03-12 |
| K253517 | Reselute Tibial Nail | Reselute, Inc. | 2026-03-10 |
| K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | 2026-03-05 |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026-03-05 |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | 2026-03-04 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases