510(k) K993768 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
CITATION TMZF HA STEM
| Applicant | Howmedica Osteonics Corp., Rutherford NJ, US |
| Decision | Substantially Equivalent, Jan 21, 2000 |
| Received | Nov 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2014 | Stryker Howmedica Osteonics Corp. Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hi Terminated |
MEH | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Dec 19, 2002 | Howmedica Osteonics Corp Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis)
Catalog No. 6265-5116 Terminated |
MEH | None listed |
| Dec 19, 2002 | Howmedica Osteonics Corp Citation TMZF HA Hip Stem Left (Femoral Hip Prosthesis)
Catalog No. 6265-5106 Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.