510(k) K973560
- Device
- BONE GRAFT HARVESTER
- Applicant
- DS MFG., INC.
- 510(k) number
- K973560
- Product code
- HWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-12
- Date received
- 1997-09-19
- Regulation
- 878.4820
- Classification name
- Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
- Medical specialty
- General & Plastic Surgery
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN A YAHIRO, M.D.
- Address
- 10605 Steamboat Landing Columbia MD US 21044 21044
FDA Registration Numbers#
- 1221053
- 3009546990
- 3008572101
- 3013820441
- 3006395932
- 8010099
- 3009732568
- 1000606483
- 8031020
- 3010375018
- 3004641308
- 3043604863
- 3043105162
- 9616088
- 1833920
- 3010303097
- 3042953190
- 3040335671
- 3007366790
- 1017294
- 1649518
- 1625507
- 3003933619
- 3004635447
- 9610612
- 2032098
- 3010673850
- 3010389204
- 8010516
- 3033536319
- 1000655211
- 3016237080
- 8040278
- 3011300255
- 2132732
- 3010287737
- 3002579136
- 3013557562
- 3003755939
- 3006217744
- 3010667733
- 3015876273
- 3005983700
- 9680741
- 1226544
- 3003604053
- 3030446844
- 1000517406
- 3015453963
- 3009973336
- 1836161
- 3004638532
- 2183744
- 3009973505
- 3010047402
- 3013700547
- 3003791208
- 3022132808
- 3007539489
- 3005706667
- 3010065126
- 3007958831
- 3017210488
- 3010178296
- 3005698350
- 1828288
- 3010041499
- 9680424
- 3006498370
- 1219602
- 3014342096
- 3014782362
- 3003393140
- 3016727307
- 3015967359
- 3012494290
- 3009888344
- 3010155648
- 3024788684
- 3021477808
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HWE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143191 | IntelliSense Drill | Mcginley Innovations | 2015-02-20 |
| K102743 | ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES | Ortho Solutions Limited | 2011-01-20 |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | The Anspach Effort, Inc. | 2007-01-16 |
| K050766 | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | Zimmer Trabecular | 2005-05-26 |
| K043310 | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM | Synthes (Usa) | 2005-01-05 |
| K022744 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Medical Device Services | 2002-09-18 |
| K012676 | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | Adven Medical | 2002-02-04 |
| K012694 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Adven Medical | 2002-02-04 |
| K990816 | AVCORE SYSTEM | Modular Cutting Systems, Inc. | 1999-09-24 |
| K973736 | AESCULAP HILAN MOTOR SYSTEM | Aesculap, Inc. | 1997-12-29 |
| K972508 | SURGICAL BURS AND SURGICAL DRILL BITS | Synvasive Technology, Inc. | 1997-08-26 |
| K971342 | DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) | Disk Whisk, Inc. | 1997-07-08 |
| K971544 | SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) | Synthes (Usa) | 1997-05-28 |
| K962087 | SERVOTRONIC EC100 SYSTEM | Medicon, Inc. | 1997-04-23 |
| K970088 | RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: | Richard Wolf Medical Instruments Corp. | 1997-04-07 |
Legacy Summary#
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FDA Review#
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