510(k) K942956
- Device
- SURGICAL INSTRUMENTS AND ACCESSORIES
- Applicant
- STRYKER CORP.
- 510(k) number
- K942956
- Product code
- HWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-09-23
- Date received
- 1994-06-23
- 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. Kalamazoo MI US 49001 49001
FDA Registration Numbers#
- 3007279848
- 3001239363
- 1424263
- 3010220595
- 3030446844
- 3023265483
- 3040335671
- 3004111573
- 3017521423
- 3010178296
- 3004358587
- 3013791180
- 3006563559
- 3012130008
- 2916714
- 3002807295
- 3021192165
- 1833920
- 3017210488
- 1649390
- 3011187779
- 3017196117
- 3026586698
- 3006498370
- 3007997036
- 3027339877
- 3002976036
- 3009251316
- 1835572
- 1319639
- 1000517406
- 3008837339
- 3005282635
- 3009732568
- 1720747
- 1833986
- 1531174
- 3022132808
- 3010389204
- 1928237
- 3004976965
- 3008110533
- 3005382983
- 1720929
- 3002736229
- 3010667733
- 2320767
- 1423537
- 1828288
- 9612501
- 1038671
- 1526711
- 3034676720
- 1020279
- 8043792
- 1226544
- 3010052483
- 3002806603
- 3014315669
- 3009656988
- 1422375
- 1644408
- 9680741
- 8040278
- 1219655
- 3009106092
- 3015399803
- 3004464325
- 3021226419
- 3031240334
- 3006638824
- 1222928
- 3010202439
- 3014725904
- 1000655158
- 3000270450
- 1526439
- 3014207283
- 9611102
- 3010123303
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#
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