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#
- 3043620689
- 9614438
- 3027339877
- 3010047454
- 1226544
- 1833986
- 3011300255
- 3014662844
- 1320894
- 3003973936
- 8044015
- 3014479313
- 3008021110
- 1000461041
- 8010916
- 1221934
- 3003477135
- 3027242374
- 3006395932
- 3019878714
- 3045075631
- 3042953190
- 3005031160
- 1000606483
- 3013055499
- 3013820441
- 3021192165
- 3043604863
- 3002806603
- 3010045785
- 3013767421
- 3018094310
- 1061927
- 3005282635
- 3001239363
- 3006638824
- 2133641
- 3010057661
- 3006438441
- 3029933740
- 3017210488
- 1720929
- 3003541440
- 9616696
- 3010470577
- 3004142400
- 8031010
- 3016851379
- 1423662
- 3004111573
- 3003933619
- 1221144
- 1222928
- 3006128100
- 3007366790
- 1828464
- 3003322138
- 3007997036
- 3003898228
- 3016438694
- 3010389204
- 3015806723
- 3036756245
- 3009380063
- 3012086357
- 3021477808
- 3010331645
- 1649390
- 3014252644
- 3015876273
- 3043148563
- 3006801265
- 3004638532
- 3011277660
- 3005061536
- 3006990600
- 8043606
- 2081135
- 3015231789
- 3005210579
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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