510(k) K934962
- Device
- AIM SUPRACONDYLAR NAIL
- Applicant
- ACE ORTHOPEDIC MANUFACTURING CO.
- 510(k) number
- K934962
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-22
- Date received
- 1993-10-18
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CLAUDE PERING
- Address
- 14105 S. Avalon Blvd. Los Angeles CA US 90061 90061
FDA Registration Numbers#
- 1834331
- 3002962587
- 3010462278
- 8030965
- 3018182995
- 3006513362
- 3003541440
- 1526534
- 3004513872
- 3012329552
- 3012755988
- 3016438694
- 1720929
- 1043534
- 3008534770
- 3010407203
- 3006846753
- 1828464
- 3013820441
- 1722511
- 3008951116
- 3005581234
- 3003935342
- 3006395932
- 1835296
- 3003898228
- 3008650117
- 3003477135
- 3015869121
- 3008749819
- 3010363503
- 3014257776
- 3009732568
- 9613350
- 8031020
- 3009189869
- 3015877656
- 3006487372
- 3009144915
- 8010177
- 1822565
- 3008599979
- 3014833750
- 3015806723
- 3004153896
- 3012724179
- 3006801265
- 3010400367
- 1833920
- 3014976005
- 3013176080
- 3011683674
- 3009380093
- 1835251
- 3009116370
- 3009554293
- 3005497913
- 3010041430
- 3014315669
- 1054811
- 3031261833
- 3005874553
- 9614438
- 3007597023
- 3007366790
- 9617297
- 3011500362
- 3004450489
- 2249697
- 3006639944
- 3015869493
- 1721676
- 3006001176
- 9615128
- 3009417901
- 1649518
- 3009141957
- 1424263
- 3010386387
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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
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