510(k) K253749
- Device
- Affixus® Natural Nail® Proximal Humeral System
- Applicant
- Zimmer Switzerland Manufacturing GmbH
- 510(k) number
- K253749
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-12
- Date received
- 2025-11-25
- Regulation
- 888.3020
- Classification name
- Rod, Fixation, Intramedullary And Accessories
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Melanie Mitrov
- Address
- Sulzerallee 8 Winterthur CH 8404 8404
FDA Registration Numbers
- 1423662
- 1450662
- 1833506
- 3014967969
- 3010287665
- 3014976005
- 1422572
- 2133928
- 3030926959
- 3007913880
- 3013820441
- 1649390
- 3009540749
- 3010364775
- 3006639944
- 3013176080
- 3010440433
- 2027062
- 3021008900
- 3009973699
- 3010386387
- 1043534
- 3010057495
- 3006801265
- 3016727307
- 3004464325
- 1835831
- 3001239363
- 3011127597
- 3018182995
- 3010041430
- 3009380093
- 3010368646
- 1644408
- 3009158523
- 2183946
- 2031009
- 3023852420
- 3013756169
- 2032098
- 1834331
- 3003541440
- 3005290844
- 3015212339
- 3010287737
- 3007420745
- 1833920
- 3015806723
- 3025603301
- 3005061536
- 3014170143
- 3034676720
- 3004142400
- 1643264
- 3030714745
- 2028632
- 3006946279
- 3004358587
- 3017435639
- 1043653
- 9680825
- 3026311512
- 3015882686
- 3000327445
- 1721676
- 3006460162
- 3005581234
- 3010120104
- 3007593722
- 3017521423
- 3010162973
- 3006395932
- 3009116370
- 3004976965
- 3027339877
- 3004635447
- 1424434
- 3002949614
- 3043620689
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code HSB
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026-03-05 |
| K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | 2026-03-05 |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | 2026-03-04 |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026-02-03 |
| K252826 | ARIX Femur Nail System | Jeil Medical Corporation | 2025-12-10 |
| K250197 | Estremo Fibular Nail | Citieffe S.R.L. | 2025-10-17 |
| K250628 | DynaNail TTC Fusion System | MedShape, Inc. | 2025-09-12 |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | 2025-08-20 |
| K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025-08-13 |