Panels › Orthopedic › Product code MEH · Class 2
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation 888.3353
2510(k)s in 12 months (160 all time)
1recalls in 12 months (197 all time)
190recalls that name a 510(k)
Top companies in MEH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Shell 58 MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, Terminated |
MEH | K912654 |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 54MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | K912654 |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 50MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | K912654 |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 48MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | K912654 |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 46MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | K912654 |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 44MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | K912654 |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 42MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | K912654 |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 40MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | K912654 |
| Apr 19, 2010 | Stryker Howmedica Osteonics Corp. Howmedica Restoration ADM Trial Cup Holder;
Non Sterile;
Benoist Girard, Cedex, France;
Distributed by Howmedica Osteonics Corp.
Mahwah, NJ.
The intended use: The Restoration ADM Window Trial is lock Terminated |
MEH | None listed |
| Dec 22, 2009 | Stryker Howmedica Osteonics Corp. Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile;
Arc Deposited, V40 taper
Not for use with 16mm heads. Terminated |
MEH | K020615 |
| Dec 22, 2009 | Stryker Howmedica Osteonics Corp. Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem; Sterile
Arc Deposited, V40 taper
Not for use with 16mm heads. Terminated |
MEH | K020615 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 60 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 55 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 50 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 45 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 40 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 35 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 30 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 25 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 20 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 15 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430. Terminated |
MEH | K873251 |
| Aug 13, 2009 | Stryker Howmedica Osteonics Corp. Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France.
Single use devices intended for cementless fixation within the prepared ace Terminated |
MEH | K013676 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle.
Hip stems are single use devices intended for cementless fixation. The products are Terminated |
MEH | K020572 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruct Terminated |
MEH | K023102 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruct Terminated |
MEH | K023102 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruct Terminated |
MEH | K023102 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Super Secur Fit Plus.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous to Terminated |
MEH | K020615 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Super Secur Fit Plus.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous to Terminated |
MEH | K020615 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Super Secur Fit Plus.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous to Terminated |
MEH | K020615 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Super Secur Fit Plus.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous to Terminated |
MEH | K020615 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Super Secur Fit Plus.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous to Terminated |
MEH | K020615 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Super Secur Fit Plus.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous to Terminated |
MEH | K020615 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Short Citation TMZF HA Hip Stem - Right;
Hydroxylapatite Coated, Titanium Plasma Spray;
V40 Taper, 132 degree neck angle: Stem Length - 102mm; Head Offset - 52mm, Distal Diameter - 16mm.
Hip stems ar Terminated |
MEH | K993768 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Citation TMZF HA Hip Stem - RT.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a p Terminated |
MEH | K993768 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Citation TMZF HA Hip Stem - RT.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a p Terminated |
MEH | K993768 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Citation TMZF HA Hip Stem - RT.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a p Terminated |
MEH | K993768 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Citation TMZF HA Hip Stem - RT.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a p Terminated |
MEH | K993768 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Citation TMZF HA Hip Stem - RT.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a p Terminated |
MEH | K993768 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Citation TMZF HA Hip Stem - LT.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a p Terminated |
MEH | K993768 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Citation TMZF HA Hip Stem - LT.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a p Terminated |
MEH | K993768 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Citation TMZF HA Hip Stem - LT.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a p Terminated |
MEH | K993768 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray;
V40 taper
Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle.
Hip stems are single use devi Terminated |
MEH | K023102 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray;
V40 taper
Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. Terminated |
MEH | K023102 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray;
V40 taper
Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle.
Hip stems are single use devi Terminated |
MEH | K023102 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray;
V40 taper
Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle.
Hip stems are single use devi Terminated |
MEH | K023102 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray;
V40 taper
Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle.
Hip stems are single use devi Terminated |
MEH | K023102 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray;
V40 taper
Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle.
Hip stems are single use devi Terminated |
MEH | K023102 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray;
V40 taper
Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle.
Hip stems are single use devi Terminated |
MEH | K023102 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray;
V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle.
Hip stems are single use devi Terminated |
MEH | K023102 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray;
V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle.
Hip stems are single use devi Terminated |
MEH | K023102 |
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