510(k) K880150
- Device
- PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
- Applicant
- DYONICS, INC.
- 510(k) number
- K880150
- Product code
- HWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-04
- Date received
- 1988-01-13
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN J SOKOLOWSKI
- Address
- 160 Dascomb Rd. Andover MA US 01810 01810
FDA Registration Numbers#
- 1833920
- 3015231789
- 1000517406
- 3009493875
- 3011277660
- 3004915132
- 3010047402
- 3004513872
- 1048735
- 2648666
- 3015882686
- 1226544
- 3009417901
- 3009656988
- 3005983700
- 3004371426
- 3014342096
- 1319639
- 1221053
- 3009546990
- 3014262693
- 3006498370
- 9614686
- 3016237080
- 3005698350
- 3006721341
- 3009380063
- 3016032497
- 3010162973
- 3020155054
- 1835251
- 1526611
- 3014747863
- 3010057661
- 3020704423
- 2249615
- 9612501
- 3010594904
- 2133641
- 3010375018
- 1643817
- 3006984710
- 3011623994
- 3037407500
- 9611579
- 2649614
- 3020978007
- 3010065126
- 9680718
- 1824199
- 3004983210
- 3025603301
- 3043604863
- 3014479313
- 3006438441
- 3008837339
- 1834331
- 3004638532
- 3010667733
- 1828464
- 3019878714
- 3005273623
- 9614438
- 1219655
- 1928237
- 3002862271
- 3018094310
- 3010155648
- 1625507
- 1222928
- 3010537287
- 3004142400
- 3009812190
- 1038671
- 1720929
- 9617426
- 3003393140
- 3009241418
- 3021192165
- 3023028944
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 |
| 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 |
| K962087 | SERVOTRONIC EC100 SYSTEM | Medicon, Inc. | 1997-04-23 |
Legacy Summary#
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FDA Review#
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