510(k) K915692
- Device
- Cannulated Drill Bit
- Applicant
- W.L. GORE & ASSOCIATES,INC
- 510(k) number
- K915692
- Product code
- HTW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-01-16
- Date received
- 1991-12-23
- Regulation
- 888.4540
- Classification name
- Bit, Drill
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDREW BERMAN
- Address
- 1500 N. Fourth St. Flagstaff AZ US 86001 86001
FDA Registration Numbers#
- 3004369035
- 1935627
- 3007728266
- 1834251
- 3042070113
- 3009468807
- 3007038972
- 3014967149
- 3003236702
- 3023155873
- 3017565094
- 3008812560
- 3004049923
- 3012086398
- 3042226236
- 1043534
- 3010331645
- 3010408671
- 3016032497
- 3015225571
- 3027339877
- 3006801265
- 9680619
- 3015259876
- 3004475955
- 3005739886
- 3019269298
- 3010509633
- 3038776593
- 2320767
- 3014262693
- 1835572
- 3013700547
- 3006108336
- 3012724179
- 3004944585
- 3005180920
- 1424434
- 3016438694
- 8030607
- 3010045785
- 1056350
- 9680515
- 2529846
- 3038187464
- 3032747418
- 3014023545
- 9611827
- 3012755988
- 1923569
- 3003596442
- 3003249380
- 8031020
- 3013912820
- 3007766601
- 2916714
- 1720747
- 1828288
- 3026311512
- 8020712
- 3009165919
- 3005067367
- 1834331
- 3034525
- 1057425
- 9611283
- 3013273457
- 3019455
- 3009996260
- 3009790163
- 3005677016
- 2133928
- 3004431266
- 3002719998
- 1824199
- 3013846070
- 3016822575
- 3012130008
- 3021477808
- 3007593722
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HTW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K151661 | Renovo Life Hard Carbon Coated Drill Bit | Renovo Life, LLC | 2016-01-15 |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | Hand Biomechanics Lab, Inc. | 1994-12-22 |
| K930339 | REAMER BIT | Neoligaments, Ltd. | 1993-08-06 |
| K892903 | MITEK ANCHOR DRILL | Mitek Surgical Products, Inc. | 1989-10-06 |
| K870217 | FEMORAL CEMENT REMOVAL INSTRUMENTS | Kenneth J. Hoek, M.D., Inc. | 1987-02-06 |
| K863147 | GLENOID DRILL | Bowen & Company, Inc. | 1986-09-05 |
| K841629 | DRILL BIT | Plastafil, Inc. | 1984-08-27 |
| K834229 | BONE PLUGGING TOOL | Standard Surgical | 1984-01-10 |
| K831712 | SURGICAL DRILL BITS | Medical Specialists IN Packaging | 1983-07-07 |
| K820226 | UNIVERSALL DRILL GUIDE | Ortho Pared Instruments, Inc. | 1982-02-04 |