510(k) K943589
- Device
- STRYKER TOTAL PERFORMANCE SYSTEM
- Applicant
- STRYKER CORP.
- 510(k) number
- K943589
- Product code
- HWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-12-15
- Date received
- 1994-07-22
- 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
- TAMMY LOUNDS
- Address
- 4100 E Milham Ave. Portage MI US 49002 49002
FDA Registration Numbers#
- 3031238646
- 3014725904
- 3032391
- 3003541440
- 3005562917
- 8010099
- 3038191237
- 1020279
- 3006990600
- 9616696
- 1000200989
- 3005083075
- 3015453963
- 3014315669
- 3014782362
- 3027339877
- 3010220595
- 3012497308
- 3016237080
- 2249615
- 3010045785
- 3004142400
- 3009812190
- 1221763
- 3011300255
- 3013756169
- 1526439
- 3011187779
- 9615765
- 3010594904
- 9680424
- 3007084590
- 3003755939
- 1043653
- 2027467
- 1720929
- 1644408
- 3010673777
- 3037407500
- 1828464
- 3013564228
- 3004774118
- 3005282635
- 2032830
- 1526611
- 3013557562
- 3007125392
- 3008572101
- 3002579136
- 1818910
- 3009590742
- 3015526568
- 3006984710
- 9614438
- 3014023545
- 3003898228
- 3014662844
- 3027339887
- 3021226419
- 3023265483
- 1065595
- 3021336182
- 3010389204
- 3024788684
- 8010516
- 3002498892
- 3010470577
- 3013767421
- 3014747863
- 3017406274
- 9611102
- 3007539489
- 3001239363
- 1320894
- 3012130008
- 3005210579
- 3001284227
- 3008837339
- 1836357
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 |
| K012694 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Adven Medical | 2002-02-04 |
| K012676 | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | 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#
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