510(k) K151661
- Device
- Renovo Life Hard Carbon Coated Drill Bit
- Applicant
- Renovo Life LLC
- 510(k) number
- K151661
- Product code
- HTW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-01-15
- Date received
- 2015-06-19
- Regulation
- 888.4540
- Classification name
- Bit, Drill
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Harold Crowder
- Address
- 1104 Spruce St. Belmont NC US 28012 28012
FDA Registration Numbers#
- 3007123908
- 3004521401
- 3004215117
- 3014725904
- 3032391
- 3008215723
- 3003541440
- 3005562917
- 3010041511
- 1923569
- 3010687973
- 1020279
- 3004369035
- 3009973699
- 3004944585
- 3007420745
- 3017482348
- 3003596442
- 3010235355
- 3015453963
- 2030624
- 3014315669
- 3033589330
- 3027339877
- 3007319107
- 3007289093
- 3014302784
- 3013273457
- 3015179588
- 3016237080
- 2249615
- 3010045785
- 3001620590
- 3004142400
- 1221763
- 8020712
- 3006215390
- 3004788213
- 3009468807
- 3004549189
- 3004153896
- 2183785
- 9680515
- 3007738812
- 1526439
- 3011187779
- 9615765
- 9680424
- 3017980495
- 8010155
- 2529846
- 3003755939
- 3043725431
- 1043653
- 3026771806
- 2027467
- 1720929
- 3005739886
- 3010659131
- 3027305775
- 1644408
- 3011196443
- 3009158523
- 3004187715
- 3005874553
- 3037407500
- 3008864603
- 1828464
- 1833506
- 3013564228
- 3025266
- 3006946279
- 3004774118
- 3010531060
- 2032830
- 1526611
- 3007125392
- 9616250
- 3002579136
Source Documents#
Other 510(k) Records For Product Code HTW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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