510(k) K834229
- Device
- BONE PLUGGING TOOL
- Applicant
- Standard Surgical
- 510(k) number
- K834229
- Product code
- HTW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-10
- Date received
- 1983-12-06
- Regulation
- 888.4540
- Classification name
- Bit, Drill
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010667733
- 3014314623
- 1221934
- 3005528784
- 3012478585
- 9610905
- 3025603301
- 9611274
- 3009996260
- 3015383864
- 3014976005
- 3002719998
- 1047843
- 1833506
- 3004983210
- 3009973844
- 3020650900
- 3008936260
- 3016669046
- 3010659131
- 3012329552
- 9611112
- 3002807295
- 9617297
- 3040266825
- 2529846
- 3012329926
- 1923569
- 3006982954
- 2087382
- 3043654467
- 9680411
- 2649614
- 3010502940
- 9610612
- 3011230048
- 3014554088
- 3016112537
- 3002949614
- 3001620590
- 3015167917
- 3015882686
- 3003988575
- 3011137372
- 3015231789
- 3007222353
- 3006561161
- 1000517406
- 3015179588
- 3012755988
- 3021336182
- 3021723305
- 1064017
- 3015453963
- 1649390
- 3007123908
- 3031261833
- 3009380063
- 3003403260
- 3009590742
- 3004358587
- 1643264
- 3007190523
- 3015259876
- 3006179046
- 3014302784
- 1000432246
- 3010047454
- 2028632
- 3006513362
- 3010470577
- 3014725904
- 3010060157
- 1833824
- 3036756245
- 1226544
- 9616671
- 8043971
- 3003477135
- 2032098
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 |
| K915692 | CANNULATED DRILL BIT | W. L. Gore & Associates, Inc. | 1992-01-16 |
| 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 |
| K831712 | SURGICAL DRILL BITS | Medical Specialists IN Packaging | 1983-07-07 |
| K820226 | UNIVERSALL DRILL GUIDE | Ortho Pared Instruments, Inc. | 1982-02-04 |