510(k) K982958
- Device
- ZETA MULTIZONE LOCKING NAIL SYSTEM
- Applicant
- HOWMEDICA CORP.
- 510(k) number
- K982958
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-11-20
- Date received
- 1998-08-24
- 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
- 359 Veterans Blvd. Rutherford NJ US 07070 07070
FDA Registration Numbers#
- 3015869493
- 1833920
- 3006639944
- 3015231789
- 3010131578
- 1000517406
- 3005061536
- 3025141
- 3009144915
- 3021336182
- 3004513872
- 3004358587
- 1644408
- 3010287737
- 3022159082
- 1835296
- 3014967969
- 3015882686
- 3010502940
- 9610726
- 3006849754
- 3014527928
- 1226544
- 3035366890
- 3006694268
- 3013302242
- 3009417901
- 3003541440
- 3010106508
- 3008868758
- 1064129
- 3003935342
- 3010470577
- 2028632
- 3009973336
- 3005874553
- 3010411051
- 3007923096
- 1643264
- 3006487372
- 3003525643
- 3010386387
- 3011388423
- 1649518
- 3017435639
- 3030926959
- 1422572
- 3016084569
- 2134285
- 1721676
- 1833506
- 1818910
- 9681465
- 3006395932
- 3000270450
- 3038503932
- 3010041499
- 3006563559
- 3010370880
- 1054811
- 3034525
- 3007366790
- 3026776
- 3019767615
- 2027062
- 1828288
- 9710312
- 3016237080
- 3010178296
- 3012724179
- 1529009
- 2133928
- 3008951116
- 3009380093
- 3010162973
- 3010606097
- 3014004349
- 3009116370
- 3013820441
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#
summary
FDA Review#
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