510(k) K042396
- Device
- T2 PROXIMAL HUMERAL NAIL
- Applicant
- HOWMEDICA OSTEONICS CORP.
- 510(k) number
- K042396
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-10-08
- Date received
- 2004-09-02
- 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
- VIVIAN KELLY
- Address
- 325 Corporate Dr. Mahwah NJ US 07430 07430
FDA Registration Numbers#
- 3010057495
- 3010370500
- 3030926959
- 3011500362
- 1835831
- 1834379
- 3002962587
- 3004976965
- 3012329552
- 3025603301
- 3015806723
- 3010411051
- 3003249380
- 1833986
- 3011127597
- 3005290844
- 1643264
- 3008650117
- 9611813
- 1051526
- 3013820441
- 3010065126
- 3009973505
- 3014315669
- 3015231789
- 3009996260
- 1424263
- 3004513872
- 9616944
- 3008102042
- 9710312
- 9615128
- 3018182995
- 3036756245
- 3016438694
- 1643817
- 3008559295
- 3016851379
- 3014273424
- 3018011420
- 3009532798
- 2022435
- 3009998573
- 3006639944
- 1220477
- 3012392319
- 3008837339
- 2032098
- 3010331645
- 3013055499
- 2183946
- 1834331
- 3021008900
- 3016237080
- 3010470577
- 1835572
- 3008749819
- 3006395932
- 3013756169
- 3006272282
- 3010368646
- 9611390
- 3023852420
- 1649518
- 3015869121
- 3006694268
- 3009144915
- 3006783837
- 1833506
- 3006513362
- 3015216945
- 1043534
- 3010162973
- 1054811
- 3010364775
- 3006128100
- 3022142628
- 2031966
- 1064129
- 3009959868
Source Documents#
Other 510(k) Records For Product Code HSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026-09-24 |
| 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 |
Legacy Summary#
summary
FDA Review#
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