510(k) K830360
- Device
- 3m Osteotomy Guide
- Applicant
- 3M COMPANY
- 510(k) number
- K830360
- Product code
- HWT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-01
- Date received
- 1983-02-03
- Regulation
- 888.4800
- Classification name
- Template
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 8124 Pacific Ave. White City OR US 97503 97503
FDA Registration Numbers#
- 3004142400
- 3016050940
- 3005677016
- 3004983210
- 3006395932
- 1531174
- 1836161
- 3015869121
- 1221763
- 9611813
- 1423662
- 3010009693
- 9613350
- 3003541440
- 1218882
- 3009882675
- 3007303113
- 3009106092
- 3003526896
- 3005144609
- 3009996260
- 2132732
- 3016822575
- 3009381600
- 1000517406
- 3013055499
- 3014315669
- 2133687
- 3009848551
- 3008668801
- 3005067367
- 3008395366
- 3007728266
- 3011390763
- 3008544874
- 9615674
- 3015877656
- 1032347
- 3014967149
- 2031910
- 3003403260
- 9710629
- 3016851379
- 9616389
- 1644408
- 3031240334
- 3006563559
- 3006411780
- 3004049923
- 3006946279
- 3010041511
- 3010363503
- 3003791208
- 3014019090
- 3014004349
- 3009756153
- 3010470577
- 3010342382
- 3007200272
- 1000297541
- 2031966
- 3005718816
- 1649379
- 3008773560
- 9617083
- 9616671
- 3020584246
- 3030926959
- 3015399803
- 9615765
- 3021723305
- 1834331
- 2249529
- 3017521423
- 3007539489
- 1111225
- 1835572
- 3015516266
- 3003418325
- 3014725904
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HWT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974406 | ORTHOPLAN | Ortho-Graphics, Inc. | 1998-02-18 |
| K960685 | ORTHODOC PREOPERATIVE PLANNER MODEL 500 | Integrated Surgical Systems, Inc. | 1997-01-17 |
| K894228 | KRONNER SPHERICAL CUTTERS | Kronner Medical | 1990-07-23 |
| K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | Warsaw Orthopedic, Inc. | 1987-05-27 |
| K871323 | ARTHROSCOPIC MENISCAL SUTURE SYSTEM | Orthopedic Systems, Inc. | 1987-05-01 |
| K811205 | MOLDED POLYSULFONE TRIAL PROSTHESIS | Shannon Group | 1981-05-21 |
| K781091 | KNEE INSTRUMENTATION, CONDYLAR | Biomet, Inc. | 1978-07-17 |
| K771709 | WORRELL TRIAL PATELLA | Depuy, Inc. | 1977-10-06 |
| K771710 | WORRELL PATELLA TEMPLATE | Depuy, Inc. | 1977-10-06 |