510(k) K033669

Device: SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
Applicant: SMITH & NEPHEW, INC.
510(k) number: K033669
Product code: HRS
Decision: Substantially Equivalent (SESE)
Decision date: 2003-12-10
Date received: 2003-11-21
Regulation: 888.3030
Classification name: Plate, Fixation, Bone
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: DAVID HENLEY
Address: 7135 Goodlett Farms Pkwy. Cordova TN US 38016 38016

FDA Registration Numbers

1450662
3016778139
9680619
3030926959
3023808054
1649390
3015131017
1043534
3004464325
3001239363
1421101
3012086398
3023852420
1834331
3003541440
3013756169
3015075784
3005290844
3013194153
1833824
1313525
3015410662
1643264
3000170817
1319660
9611579
3017521423
2028523
3027339877
3002949614
9612277
3009756327
8010177
3010846112
2249697
3010863450
3019767615
3010331645
1531050
3008696586
3006128100
1225838
3002962587
3007648354
3010118938
1030489
3012478585
3017609305
3029933740
3017191784
2183449
2183967
1060840
3006001176
3005751028
3002807295
3009196021
1061927
3009189869
3009887475
9616680
1221053
3010047454
3016247852
3014315669
3009973505
8030965
3016761372
3012447612
3021336182
9610622
3006017180
3016237080
1835296
3009153862
1032347
3008599979
2029275
9615128

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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Legacy Summary

summary

FDA Review

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