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#
- 3025266
- 9617297
- 1720747
- 1226544
- 3023265483
- 9614438
- 1528668
- 3012104767
- 9680411
- 3006801265
- 3010047402
- 3030514683
- 8043496
- 3008864603
- 3006846753
- 3003139373
- 3033589330
- 3009554293
- 3010400367
- 3006563559
- 2032830
- 3015991317
- 3004187715
- 3008936260
- 3021336182
- 2031009
- 3011230048
- 3026576110
- 3032391
- 3007193505
- 3012697315
- 3036756245
- 3034676720
- 3013540005
- 1219655
- 1828288
- 1038671
- 3005751028
- 3033536312
- 3009756327
- 3016112537
- 3003755939
- 1036836
- 3010673515
- 3006034256
- 1421101
- 3016443334
- 3004893332
- 3043654467
- 2028632
- 3008021110
- 3010408671
- 3015309643
- 3009423112
- 1222928
- 2030624
- 3027339877
- 3005809810
- 3025608439
- 3008110533
- 3010363503
- 2320767
- 3017565094
- 3013156185
- 1047843
- 3031240334
- 3014262693
- 3016822575
- 3009590742
- 3024856795
- 1219602
- 1000422168
- 3010331645
- 3027305775
- 1526439
- 1834251
- 3005528784
- 3008337808
- 1221763
- 3008599979
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 |