Product Code: HTW


Products Classified as HTW

4484Bit, DrillOrthopedic Manual Surgical Instrument.

Total Product Life Cycle (TPLC) Devices

4484Bit, DrillOrthopedic Manual Surgical Instrument.

FDA Consensus Standards

Bit, Drill [37411]21 CFR §888.4540 🔎
Bit, Drill [31853]21 CFR §888.4540 🔎
Bit, Drill [37809]21 CFR §888.4540 🔎
Bit, Drill [29702]21 CFR §888.4540 🔎
Bit, Drill [31985]21 CFR §888.4540 🔎
Bit, Drill [37414]21 CFR §888.4540 🔎

Pre-market Notifications for HTW

K151661Renovo Life Hard Carbon Coated Drill BitRenovo Life LLC
K942906AGEE-WRISTJACK PRE-DRILL KITHAND BIOMECHANICS LAB, INC.
K930339REAMER BITNEOLIGAMENTS, LTD.
K892903MITEK ANCHOR DRILLMITEK SURGICAL PRODUCTS, INC.
K863147GLENOID DRILLBOWEN & COMPANY, INC.
K841629DRILL BITPLASTAFIL, INC.
K831712SURGICAL DRILL BITSMEDICAL SPECIALISTS IN PACKAGING
K820226UNIVERSALL DRILL GUIDEORTHO PARED INSTRUMENTS, INC.

Global Unique Device Identification Database

00192896091245BIT, DRILL
00192896091238BIT, DRILL
00192896090934BIT, DRILL
00192896090927BIT, DRILL
00192896090910BIT, DRILL
00192896090903BIT, DRILL
00192896090897BIT, DRILL
00192896090880BIT, DRILL
00192896090866BIT, DRILL
00192896090859BIT, DRILL
00192896090101BIT, DRILL
00192896090095BIT, DRILL
00192896090088BIT, DRILL
00613994894779BIT, DRILL
00613994877963BIT, DRILL

Maude Adverse Events

45 DEG ANGLE DRILLDEPUY ORTHOPAEDICS INC US2020-03-31
4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATIONOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
2.8MM CALIBRATED DRILL BIT QC 250MM/95MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
2.8MM CALIBRATED DRILL BIT QC 250MM/95MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
DRILL BITSYNTHES (U.S.A.) LP2020-03-31
DRILL STANDARD 2.0 MM DIAMETERZIMMER BIOMET, INC.2020-03-31
UNK - DRILL BITS: TRAUMAOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-30
APG+ QC CENT BIT 40 44DEPUY ORTHOPAEDICS INC US2020-03-30
QUICKSET 1PC FLEX DRILL BIT 25DEPUY ORTHOPAEDICS INC US2020-03-30
UNK - DRILL BITS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-30
QUICKSET 1PC FLEX DRILL BIT 35DEPUY ORTHOPAEDICS INC US2020-03-30
UNK - DRILL BITS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-30
QUICKSET 1PC FLEX DRILL BIT 45DEPUY ORTHOPAEDICS INC US2020-03-27
QUICKSET 1PC FLEX DRILL BIT 35DEPUY ORTHOPAEDICS INC US2020-03-27
QUICKSET 1PC FLEX DRILL BIT 30DEPUY ORTHOPAEDICS INC US2020-03-27
DRILL BIT 3.2 DIA 25MM LENGTHDEPUY ORTHOPAEDICS INC US2020-03-27
BIT, DRILLSTRYKER ENDOSCOPY2020-03-27
QUICKSET 1PC FLEX DRILL BIT 30DEPUY ORTHOPAEDICS INC US2020-03-26
UNK INSERTION DEVICEDEPUY ORTHOPAEDICS INC US2020-03-26
QUICKSET 1PC FLEX DRILL BIT 25DEPUY ORTHOPAEDICS INC US2020-03-26
QUICKSET 1PC FLEX DRILL BIT 25DEPUY ORTHOPAEDICS INC US2020-03-26
2.0MM DRILL BIT WITH DEPTH MARK/QC/140MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-26
3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-26
2.0MM DRILL BIT WITH DEPTH MARK/QC/140MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-26
QUICKSET 1PC FLEX DRILL BIT 35DEPUY ORTHOPAEDICS INC US2020-03-26
DRILL BIT 2.0MM X 123MM CALIBRATEDORTHO SOLUTIONS UK LTD2020-03-26
45 DEG ANGLE DRILLDEPUY ORTHOPAEDICS INC US2020-03-25
QUICKSET 1PC FLEX DRILL BIT 30DEPUY ORTHOPAEDICS INC US2020-03-25
10MM CANNULATED TAPERED DRILL BITWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-25
T6 HEXALOBULAR DRIVE AO 2.0MMZIMMER BIOMET, INC.2020-03-24
AO QC DRILL BIT 2.5/110/85 (GOLD)ORTHO SOLUTIONS UK LTD2020-03-24
17.8MM DRILL BIT LARGE QC/312MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-24
QUICKSET 1PC FLEX DRILL BIT 25DEPUY ORTHOPAEDICS INC US2020-03-23
LUPINE STABILIZATION DRBT *EADEPUY MITEK LLC US2020-03-23
LUPINE STABILIZATION DRBT *EADEPUY MITEK LLC US2020-03-23
QUICKSET 1PC FLEX DRILL BIT 25DEPUY ORTHOPAEDICS INC US2020-03-23
DRILL BIT QUICK-CONNECT 2.5 MM DIAMETER 110 MM LENGTHZIMMER BIOMET, INC.2020-03-23
UNK - DRILL BITS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-19
UNK - DRILL BITS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-19
FLEXIBLE DRILLUNITED ORTHOPEDIC CORPORATION2020-03-17
QUICKSET 1PC FLEX DRILL BIT 25DEPUY ORTHOPAEDICS INC US2020-03-17
3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-17
UJOINT SCRW DRVR BIT 3.5 HEXZIMMER BIOMET, INC.2020-03-17
QUICKSET 1PC FLEX DRILL BIT 25DEPUY ORTHOPAEDICS INC US2020-03-16
QUICKSET 1PC FLEX DRILL BIT 25DEPUY ORTHOPAEDICS INC US2020-03-16
BIT, DRILLMEDTRONIC SOFAMOR DANEK USA, INC2020-03-14
1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-14
QUICKSET 1PC FLEX DRILL BIT 25DEPUY ORTHOPAEDICS INC US2020-03-13
UNK - DRILL BITS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-13
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