510(k) K921131
- Device
- CKS OSCILLATING SAW BLADE
- Applicant
- TECHMEDICA, INC.
- 510(k) number
- K921131
- Product code
- HWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-06-08
- Date received
- 1992-03-10
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID SAMSON
- Address
- 1380 Flynn Rd. Camarillo CA US 93010 93010
FDA Registration Numbers#
- 3013497507
- 1526350
- 3008021110
- 3003541440
- 1834379
- 1000655211
- 3004142400
- 3027339877
- 3015539532
- 3015212339
- 3027339887
- 1720747
- 3017210488
- 1720929
- 3000931034
- 1000200989
- 3005031160
- 3010173425
- 8040278
- 3005983700
- 2133641
- 3009423112
- 3010123256
- 3006498370
- 8043606
- 3005180920
- 3004371426
- 3015399803
- 3031240334
- 3030412764
- 3004111573
- 3013756169
- 2648666
- 8044015
- 1221144
- 3008668801
- 1000655158
- 3011300255
- 1221053
- 8031020
- 1645151
- 3021393544
- 3017521423
- 2133928
- 1835251
- 9680424
- 3010667733
- 3023028944
- 3012883081
- 3012358417
- 3025603301
- 2027467
- 2132732
- 3002907620
- 3016438694
- 3014747863
- 1221763
- 3021010222
- 3010389204
- 3007084590
- 3012494290
- 3013700547
- 1320894
- 3010039400
- 8010379
- 3006272282
- 3012130008
- 3011623994
- 3012497308
- 9616088
- 3015440604
- 3009732568
- 9680741
- 3013791180
- 1422634
- 3010363503
- 9616671
- 3009546990
- 3001348298
- 3014252644
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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