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#
- 1935627
- 3007728266
- 1221144
- 1319639
- 3008812560
- 1043534
- 3010331645
- 3016032497
- 3027339877
- 3006801265
- 9680619
- 3003898228
- 3019269298
- 2320767
- 3014262693
- 1835572
- 3013700547
- 3005180920
- 9616696
- 1424434
- 3016438694
- 1000655158
- 8030607
- 3010045785
- 2081135
- 3014023545
- 3014747863
- 9680718
- 3008868758
- 8031020
- 3014252644
- 2916714
- 1720747
- 1828288
- 3027339887
- 3005067367
- 1834331
- 3010393565
- 3034525
- 3010041499
- 3012497308
- 3043620689
- 3010370880
- 3005677016
- 2133928
- 1824199
- 3012130008
- 3021477808
- 3016727307
- 3016851379
- 3017210488
- 3008114965
- 1649518
- 1061927
- 3011623994
- 2183744
- 3007193505
- 3009417901
- 3010173425
- 2648666
- 3006984710
- 3009599228
- 3037027197
- 3007305485
- 3004976965
- 3021010222
- 3025764223
- 3002907620
- 8010257
- 1320894
- 3006990600
- 3015539532
- 8010916
- 9611102
- 1054811
- 3009251316
- 3014315669
- 3010388970
- 1020279
- 2020601
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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