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#
- 3037407500
- 3013557562
- 3007305485
- 1061124
- 3009888344
- 3006438441
- 3011277660
- 8031020
- 3015539532
- 1000655158
- 3014725904
- 9680424
- 1030489
- 3013820441
- 3015440604
- 9681479
- 3002976036
- 1835251
- 1834331
- 3004638532
- 1043534
- 3005827567
- 1000606483
- 3010536692
- 3015231789
- 1000461041
- 3005706667
- 2132732
- 1423537
- 1720747
- 3002498892
- 9610622
- 1645151
- 3006990600
- 1424434
- 3004641308
- 3002907620
- 3004358587
- 3012883081
- 3003755939
- 3034676720
- 3008668801
- 1219655
- 3004976965
- 9616696
- 1833920
- 3010537287
- 3025764223
- 3005562917
- 3005751028
- 3020978007
- 1221144
- 3033509898
- 3010045785
- 3009141957
- 8043862
- 1625507
- 3005067367
- 3014023545
- 3005273623
- 3025603301
- 3009582259
- 3011623994
- 3003541440
- 3009590742
- 3010047402
- 3021010222
- 3009251316
- 1818910
- 8010099
- 3020155054
- 1833986
- 3015974593
- 3010375018
- 3016032497
- 3006984710
- 9610612
- 3008868758
- 3003604053
- 3014662844
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 |
| 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#
summary
FDA Review#
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