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#
- 9617297
- 3003916006
- 3011580264
- 1226544
- 3023265483
- 9614438
- 3007051929
- 3006801265
- 3010047402
- 1038806
- 3008864603
- 3006846753
- 3003139373
- 3009554293
- 3009871135
- 3009827000
- 3010400367
- 3006563559
- 3010470577
- 3015991317
- 2031009
- 3015869121
- 3011230048
- 3011295718
- 3010646402
- 2531477
- 3036756245
- 3034676720
- 3010039400
- 1219655
- 1828288
- 1038671
- 3005751028
- 3001284227
- 3030638495
- 3009882462
- 2133687
- 3006217744
- 1421101
- 3016443334
- 3014680740
- 3008788129
- 3008021110
- 3027339877
- 3015869492
- 3005809810
- 3010363503
- 9617229
- 3017565094
- 3013156185
- 3031240334
- 3014262693
- 3011302692
- 3016822575
- 3009590742
- 1219602
- 3010331645
- 1526439
- 3006232063
- 1221763
- 3004774118
- 2029275
- 3003604053
- 3010041430
- 3014314623
- 3015167917
- 1064129
- 9616671
- 3008668801
- 9680515
- 3008793310
- 3003637761
- 1043534
- 3015516266
- 3008650117
- 3015383864
- 8010177
- 3003596442
- 3011623994
- 3009173317
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 |