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#
- 3045075631
- 1045834
- 2025102
- 1834379
- 3030446844
- 3014262693
- 3012818475
- 1526534
- 3010400367
- 1030489
- 3004464325
- 3008868758
- 8010177
- 3003541440
- 3016727307
- 3015882686
- 3014315669
- 3010393565
- 3015453963
- 1221144
- 3010047402
- 9617426
- 1220477
- 3004598644
- 8044015
- 3010039400
- 3004111573
- 3012497308
- 2028523
- 3037027197
- 3007958831
- 1828288
- 3014903258
- 3003933619
- 3003322138
- 2648666
- 1000606483
- 1000655158
- 1450662
- 3015526568
- 3016237080
- 3005382983
- 1226424
- 3011024991
- 9610612
- 3034676720
- 3014479313
- 3010047454
- 3013557562
- 3014782362
- 3002976036
- 3004635447
- 3013011598
- 3019269298
- 3003898228
- 3000931034
- 3004371426
- 3004976965
- 1531174
- 3010041499
- 3027242374
- 8043606
- 1625507
- 3007366790
- 1061927
- 3011230048
- 1824199
- 3015516266
- 1424263
- 3016851379
- 1928237
- 3010470577
- 3021336182
- 3012358417
- 3008668801
- 1834331
- 2020601
- 1720929
- 8030965
- 1054811
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases