510(k) K031438
- Device
- ACUMED SMALL BONE LOCKING ROD SYSTEM II
- Applicant
- ACUMED LLC
- 510(k) number
- K031438
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-07-17
- Date received
- 2003-05-06
- 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
- ED BOEHMER
- Address
- 5885 NW Cornelius Pass Rd. Hillsboro OR US 97124 97124
FDA Registration Numbers#
- 3016851379
- 3015806723
- 3007913880
- 3019269298
- 9614438
- 2953359
- 3005497913
- 3014967149
- 3009381600
- 3026311512
- 3043620689
- 1828288
- 3010106508
- 3004464325
- 1220477
- 3006783837
- 3004049923
- 3000270450
- 3035366890
- 2032098
- 3013055499
- 1835572
- 9710312
- 3010097171
- 3007125392
- 3011302692
- 1833986
- 3008812251
- 3010162973
- 1825034
- 3004513872
- 3016727307
- 3004358587
- 3002807295
- 3007366790
- 3009971621
- 3010287665
- 3010120104
- 3006801265
- 3026776
- 3004638532
- 3021008900
- 3014257776
- 3013820441
- 3034525
- 3015869492
- 3014314623
- 3003108161
- 3006846753
- 3008102042
- 3013756169
- 3009996260
- 3007539489
- 3010386387
- 3007441485
- 3007344102
- 3005061536
- 3009756327
- 3011388423
- 3009141957
- 3011127597
- 3018182995
- 1051526
- 1423662
- 2133928
- 3010370880
- 3006001176
- 3014967969
- 1043534
- 3016261131
- 1720929
- 3003898228
- 3022159082
- 3006128100
- 1043653
- 1054811
- 3014833750
- 3010364775
- 3014273424
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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