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#
- 3038776593
- 3004142400
- 3016050940
- 3024856795
- 3005677016
- 3004983210
- 3006395932
- 3011307621
- 1531174
- 9611102
- 3001239363
- 9616250
- 1836161
- 3010131978
- 1221763
- 3010509633
- 3019356409
- 2936485
- 9611813
- 1423662
- 3010009693
- 9613350
- 3003541440
- 3042765769
- 3019455
- 3009882675
- 3008323540
- 3009106092
- 3003526896
- 3011513267
- 3009996260
- 3016822575
- 2132732
- 3009381600
- 2244478
- 9680825
- 3012329552
- 3032747418
- 1000517406
- 3013055499
- 3014315669
- 3006034256
- 3005067367
- 9613926
- 3007193505
- 3007728266
- 2529846
- 3008544874
- 3004944585
- 9615674
- 3015877656
- 1032347
- 3026576110
- 1036836
- 3014967149
- 3003403260
- 3014967969
- 9710629
- 3016851379
- 1644408
- 3006700424
- 3031240334
- 3006563559
- 3009973699
- 2031917
- 3004049923
- 3006946279
- 3010041511
- 3010363503
- 3014004349
- 3009141957
- 2649614
- 3010470577
- 3015151147
- 2031966
- 1424434
- 3043725431
- 3025266
- 3005983700
- 2087382
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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