510(k) K070756 ยท MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jun 6, 2007 |
| Received | Mar 20, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070756
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
42MM 71331842
48MM 71331848
50MM 71331850
52MM 71331852
54MM 71331854
56MM 71 Open, Classified |
MBL | None listed |
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
42MM 71332242
46MM 71332246
48MM 71332248
50MM 71332250
52MM 71332 Open, Classified |
MBL | None listed |
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
40MM 71335540
42MM 71335542
44MM 71335544
46MM 71335546
48MM 71335548
50MM Open, Classified |
MBL | None listed |
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
42MM 71331942
46MM 71331946
48MM 71331948
50MM 71331950
52MM 7133 Open, Classified |
MBL | None listed |
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Sizes REF/product number
48MM 71338663
50MM 71338664
52MM 71338665
54MM 71338666
56MM 71338667
58MM Open, Classified |
MBL | None listed |
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
48MM 71338733
50MM 71338734
52MM 71338735
54MM 71338736
56MM 7133 Open, Classified |
MBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.