510(k) K902525
- Device
- ACE/WILLIAMS MICROSURGERY SAW SYSTEM
- Applicant
- BUCKMAN CO., INC.
- 510(k) number
- K902525
- Product code
- HWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-11-26
- Date received
- 1990-06-05
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- W SCHLERF
- Address
- 1000 Burnett Ave., Suite 450 Concord CA US 94520 94520
FDA Registration Numbers#
- 3020899789
- 2249615
- 3009380063
- 3002579136
- 1320894
- 3006721341
- 3004598644
- 1424434
- 1644408
- 3015967359
- 3023028944
- 1043534
- 3042953190
- 3025603301
- 3013700547
- 3034676720
- 3014725904
- 1045254
- 3006128100
- 9611102
- 3003322138
- 3009590742
- 3027339887
- 3006217744
- 3002498892
- 1220246
- 8010516
- 3010123303
- 1720929
- 3017406274
- 3010173425
- 3007728266
- 8010099
- 1835251
- 8043606
- 3031238646
- 9680718
- 3000270450
- 3010041499
- 3010178296
- 1423537
- 1835572
- 1450662
- 3043105162
- 3002976036
- 3006272282
- 3010047454
- 3040335671
- 2647346
- 3021226419
- 3004111573
- 3003541440
- 3030447506
- 3009106092
- 3012494290
- 8043792
- 3005983700
- 3007305485
- 3015806723
- 3008868758
- 1061124
- 3011674645
- 3009251316
- 3006990600
- 3007958831
- 1935627
- 3003933619
- 3011823740
- 9680424
- 2025102
- 3017521423
- 9610617
- 3008959444
- 1000200989
- 3006984710
- 3004154314
- 3007084590
- 3015876273
- 1048735
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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