510(k) K101939
- Device
- OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM
- Applicant
- MERETE MEDICAL GMBH
- 510(k) number
- K101939
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-10-07
- Date received
- 2010-07-12
- 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
- DONNA COLEMAN
- Address
- 49 Purchase St. Rye NY US 10580 10580
FDA Registration Numbers#
- 3010407203
- 3004142400
- 3008812560
- 2027062
- 3004983210
- 3011127597
- 3006395932
- 3007366790
- 3012724179
- 3005497913
- 3001239363
- 3011053036
- 3010178296
- 3010041499
- 3008868758
- 1828464
- 3015869121
- 3031261833
- 3015216945
- 3016084569
- 3010440433
- 1649390
- 1221763
- 1825034
- 1833506
- 1833986
- 1423662
- 3009189869
- 3010068573
- 9613350
- 3014976005
- 1450662
- 9611813
- 3003541440
- 1935627
- 3004976965
- 3004638532
- 3008749819
- 3005562917
- 3015876273
- 3015946784
- 3005144609
- 3004369035
- 3006801265
- 3009996260
- 2134285
- 3009971621
- 3009381600
- 3036756245
- 3008559295
- 1643264
- 3009756327
- 3010220595
- 3006272282
- 1722511
- 3008198024
- 1822565
- 9680825
- 3012329552
- 3006128100
- 3015806723
- 3014527928
- 3007344102
- 3010041430
- 1000517406
- 3008599979
- 3009540749
- 3013055499
- 1720929
- 3014315669
- 3010368646
- 3025603301
- 3025141
- 3007420745
- 3006849754
- 1721676
- 3004450489
- 3003525643
- 3000327445
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#
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