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#
- 2031009
- 3021477808
- 3009051471
- 3015806723
- 3010197239
- 9614438
- 1526534
- 3003694247
- 3009865268
- 2320767
- 3043355002
- 3005809810
- 8043734
- 3005641619
- 2183449
- 3015451162
- 9613079
- 3003973936
- 3002719998
- 3025608439
- 3015877656
- 9611112
- 8023007
- 3008114965
- 3010388970
- 3006721341
- 8031010
- 3001620590
- 3014262693
- 3016851379
- 3010160527
- 3010560653
- 3005751028
- 1038671
- 3009513193
- 1054811
- 3008544874
- 8020712
- 3015991317
- 9680825
- 9617297
- 3025141
- 3009468807
- 3021010222
- 3030926959
- 3016669046
- 1721504
- 3000327445
- 3011301313
- 3038503932
- 3013011598
- 3006742481
- 3023155873
- 3009582259
- 3010303097
- 9613910
- 1828288
- 9613350
- 3012966183
- 3014207283
- 3002907620
- 1064017
- 3006513362
- 3007366790
- 3004142400
- 3014662844
- 2020601
- 3015539532
- 1045834
- 3011365613
- 3023852420
- 3038187464
- 8031020
- 3032391
- 3010502940
- 1030489
- 3010173425
- 3009971621
- 3019356409
- 3017565094
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 |