510(k) K043310
- Device
- SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
- Applicant
- SYNTHES (USA)
- 510(k) number
- K043310
- Product code
- HWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-01-05
- Date received
- 2004-12-01
- 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
- LISA M BOYLE
- Address
- 1690 Russell Rd. Paoli PA US 19301 19301
FDA Registration Numbers#
- 1720747
- 1226544
- 3023265483
- 9614438
- 1000606483
- 3002806603
- 3006801265
- 3010047402
- 3009493875
- 3038503572
- 3004111573
- 9681479
- 3010400367
- 3006563559
- 3010470577
- 3012497308
- 2032830
- 3021336182
- 3011230048
- 3010370880
- 3032391
- 3007193505
- 3036756245
- 3005282635
- 3034676720
- 1221144
- 3010039400
- 1219655
- 1828288
- 1038671
- 3005751028
- 3001284227
- 3010375018
- 3027242374
- 3003755939
- 3010673777
- 3006217744
- 3007913880
- 3008021110
- 3009423112
- 1222928
- 3027339877
- 3008110533
- 3010363503
- 2320767
- 3031240334
- 3014262693
- 3014252644
- 3009590742
- 1219602
- 3011277660
- 3010331645
- 1423537
- 1526439
- 1000655211
- 1221763
- 9616696
- 3004774118
- 2029275
- 3003604053
- 2649614
- 1424263
- 8010516
- 8030965
- 9616671
- 3008668801
- 2020550
- 1043534
- 3017196117
- 3005562917
- 3015516266
- 8010177
- 3011623994
- 3003898228
- 3008951116
- 3005983700
- 3012494290
- 3024788684
- 3017406274
- 3009656988
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 |
| 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 |
| 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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