Panels › Orthopedic › Product code HSD · Class 2
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Regulation 888.3690
0510(k)s in 12 months (71 all time)
0recalls in 12 months (19 all time)
19recalls that name a 510(k)
Top companies in HSD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2020 | Exactech, Inc. Equinoxe Humeral Stem, Primary, Press Fit, 11mm Open, Classified |
HSD | K042021 |
| Nov 16, 2018 | Ascension Orthopedics, Inc Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW Terminated |
HSD | K062861 |
| Jun 4, 2018 | Fx Solutions Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000
Product Usage:
Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions suscept Terminated |
HSD | K111097 |
| Jun 4, 2018 | Fx Solutions Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019
Product Usage:
Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susce Terminated |
HSD | K111097 |
| Dec 8, 2017 | Zimmer Biomet, Inc. Humeral Stem 55mm(Size 13)
Product Usage:
Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty Terminated |
HSD | K060692 |
| Dec 8, 2017 | Zimmer Biomet, Inc. Humeral Stem 83mm(Size 17)
Product Usage:
Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty Terminated |
HSD | K060692 |
| Aug 31, 2017 | DePuy Orthopaedics, Inc. DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional ro Terminated |
HSD | K120174 |
| Sep 2, 2015 | Limacorporate S.p.A SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery. Terminated |
HSD | K100858 |
| Feb 12, 2015 | Arthrosurface, Inc. Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic sh Terminated |
HSD | K023096 |
| Feb 12, 2015 | Arthrosurface, Inc. Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic should Terminated |
HSD | K023096 |
| Feb 12, 2015 | Arthrosurface, Inc. Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulde Terminated |
HSD | K023096 |
| Feb 12, 2015 | Arthrosurface, Inc. Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shou Terminated |
HSD | K023096 |
| Feb 12, 2015 | Arthrosurface, Inc. Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoul Terminated |
HSD | K023096 |
| Jul 10, 2013 | Zimmer, Inc. Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm
This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. h Terminated |
HSD | K110791 |
| Apr 17, 2013 | Synvasive Technology Inc The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED
For use with Stryker System 5, System 4, System 2000 and EDH.
Product Usage: For use with Stryker System 5, System 4, System Terminated |
HSD | K911902 |
| Nov 12, 2009 | Zimmer Inc. Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13.
Shoulder replacement surgery. Terminated |
HSD | K041549 |
| Nov 12, 2009 | Zimmer Inc. Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13.
Shoulder replacement surgery. Terminated |
HSD | K041549 |
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Reunion HA Fracture Stem
These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total Terminated |
HSD | K070963 |
| Dec 11, 2008 | Acumed LLC Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 " Terminated |
HSD | K992525 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.