510(k) K960720
- Device
- EXACTECH STERILE MODULAR DRILL BIT
- Applicant
- EXACTECH, INC.
- 510(k) number
- K960720
- Product code
- HWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-23
- Date received
- 1996-02-22
- 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
- MARTHA C MILLER
- Address
- 4613 NW 6th St. Gainesville FL US 32609 32609
FDA Registration Numbers#
- 3021477808
- 3015806723
- 9614438
- 1526534
- 2320767
- 3003973936
- 3011674645
- 3010202439
- 3004635447
- 3007305485
- 3012497308
- 3008114965
- 3010155648
- 3010388970
- 3006721341
- 9610617
- 3014262693
- 3007958831
- 3016851379
- 3005827567
- 1038671
- 3005751028
- 1054811
- 3017196117
- 3025141
- 3021010222
- 9610622
- 3030926959
- 8044015
- 3011300255
- 3013011598
- 3009582259
- 3010303097
- 3029933740
- 1828288
- 9613350
- 3014207283
- 3002907620
- 3007366790
- 3004142400
- 3014662844
- 2020601
- 3015539532
- 1045834
- 3026586698
- 3023852420
- 8031020
- 3032391
- 1030489
- 3010173425
- 3002579136
- 3009251316
- 9615765
- 3012494290
- 3011823740
- 9681479
- 1000606483
- 3006563559
- 3027339877
- 3014747863
- 3009590742
- 3017406274
- 1048735
- 9680741
- 3003322138
- 3016032497
- 3008951116
- 1226424
- 3038191237
- 3009546990
- 3001592626
- 1043653
- 1935627
- 2025102
- 3010162973
- 3006498370
- 1834331
- 3036756245
- 8010099
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#
summary
FDA Review#
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