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#
- 3014747863
- 1423537
- 3010594904
- 3010673777
- 1526611
- 3006563559
- 3013756169
- 9610622
- 3013700547
- 3013893019
- 3010287737
- 2320767
- 3010400367
- 3008110533
- 3010047454
- 2020601
- 9680741
- 1043653
- 3008868758
- 1644408
- 1928237
- 3014725904
- 3008959444
- 1220477
- 3010047402
- 3010273872
- 3005031160
- 3006272282
- 3009417901
- 3021010222
- 3015831087
- 3011300255
- 3011230048
- 1822565
- 3006990600
- 3005698350
- 3013791180
- 3010536692
- 1000655211
- 1061124
- 3008572101
- 3015967359
- 9616696
- 3005751028
- 1935627
- 3004915132
- 2134285
- 3030733800
- 1828464
- 3016904853
- 3004513872
- 2916714
- 3006801265
- 1834331
- 1054811
- 1030489
- 3023028944
- 1424263
- 3042953190
- 3011024991
- 3008236846
- 3012818475
- 3002736229
- 8031020
- 1043534
- 8010099
- 3010052483
- 3030412764
- 3007958831
- 2032098
- 3005827567
- 1065595
- 1833920
- 9614686
- 3004464325
- 3010673850
- 3009106092
- 3029933740
- 3003755939
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 |
| K012694 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Adven Medical | 2002-02-04 |
| K012676 | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | 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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