510(k) K962087
- Device
- SERVOTRONIC EC100 SYSTEM
- Applicant
- MEDICON, INC.
- 510(k) number
- K962087
- Product code
- HWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-23
- Date received
- 1996-05-28
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HOWARD M HOLSTEIN, ESQ.
- Address
- 555 Thirteenth St. NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3016851379
- 3004154314
- 3007289093
- 8010379
- 3004464325
- 3013055499
- 3007125392
- 1045834
- 3005827567
- 3013557562
- 3016727307
- 3004358587
- 3005273623
- 3007366790
- 8010099
- 3004638532
- 3034525
- 1221934
- 3021226419
- 3012497308
- 3011024991
- 3020899789
- 3008959444
- 1423662
- 2133928
- 1043534
- 3010673777
- 3010537287
- 3003898228
- 3006128100
- 3009106092
- 1526711
- 3026586698
- 3009590742
- 3037407500
- 3010389204
- 1000655211
- 1928237
- 3007279848
- 3005677016
- 3043604863
- 3014725904
- 3005751028
- 3005180920
- 3005031160
- 8010177
- 3009732568
- 3011823740
- 3006638824
- 3030926959
- 3017521423
- 3007084590
- 3009417901
- 2648666
- 3013564228
- 8010516
- 3018094310
- 3013893019
- 3008951116
- 3010123256
- 2134285
- 3010178296
- 3010363503
- 3002498892
- 3020704423
- 2132732
- 3003604053
- 3016438694
- 9614686
- 3011623994
- 3021477808
- 1824199
- 3012086357
- 3037027197
- 9611102
- 1644408
- 3010536692
- 3010470577
- 9612501
- 9680718
Source Documents#
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 |
| K973560 | BONE GRAFT HARVESTER | Ds Mfg., Inc. | 1997-11-12 |
| 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 |
| 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#
summary
FDA Review#
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