510(k) K080625
- Device
- SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K080625
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-05-08
- Date received
- 2008-03-05
- Regulation
- 888.3358
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- RISHI SINHA
- Address
- 1450 Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers
- 1423662
- 1450662
- 1833506
- 3002807090
- 3027484613
- 3004641308
- 2242737
- 3005180920
- 3000236920
- 2133928
- 3007913880
- 1000547811
- 3009241418
- 3006085220
- 3013176080
- 3002807315
- 3017410889
- 3021008900
- 3007334927
- 3010386387
- 2134470
- 3010057495
- 3006801265
- 3014252644
- 3009871135
- 2183744
- 3016778562
- 3012275107
- 8044172
- 1644408
- 3023852420
- 1834331
- 3003541440
- 1226188
- 1018470
- 3010287737
- 3000264985
- 3013791180
- 3007420745
- 3005323511
- 1833920
- 1827096
- 3006809628
- 3002807112
- 3009760038
- 3020162561
- 3003595343
- 3025603301
- 3005061536
- 2032521
- 3010163695
- 3004142400
- 1643264
- 3006946279
- 3026771806
- 1043653
- 1219655
- 9610612
- 2246552
- 3009106092
- 3014763043
- 2648920
- 3007740680
- 3002806535
- 1721676
- 3015516266
- 3005581234
- 3009475821
- 3010041693
- 3006395932
- 1218882
- 3004635447
- 1064858
- 3002807314
- 9611390
- 3004153896
- 3013302242
- 3007923096
- 3010041993
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03596010619655 | SMF, STIKTITE | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010619648 | SMF, STIKTITE | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010619631 | SMF, STIKTITE | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010619624 | SMF, STIKTITE | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010619617 | SMF, STIKTITE | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010619600 | SMF, STIKTITE | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010619594 | SMF, STIKTITE | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010619587 | SMF, STIKTITE | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010619570 | SMF, STIKTITE | Smith & Nephew, Inc. | 2015-08-30 |
Legacy Summary
summary
FDA Review
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