Atlas FDA

SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM

FDA 510(k) clearance K043310 · decided 2005-01-05

Clearance details

K-number
K043310
Device name
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
Applicant
Synthes (Usa)
Decision
Substantially Equivalent
Date received
2004-12-01
Decision date
2005-01-05
Days to decision
35 days
Clearance type
Traditional
Product code
HWE
Device class
1
Regulation number
878.4820
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Paoli, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile recall (Z-0681-2017)Synthes (USA) Products LLC2016-12-01
Light Adaptor for Small Battery Drive and Small Battery Drive II. recall (Z-2783-2016)The Anspach Effort, Inc.2016-09-27
Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adapt recall (Z-2784-2016)The Anspach Effort, Inc.2016-09-27
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/20 recall (Z-2199-2016)Synthes (USA) Products LLC2016-07-12
Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for s recall (Z-1313-2015)Synthes, Inc.2015-03-23
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen recall (Z-0615-2014)Synthes USA HQ, Inc.2013-12-31

PMA approvals by this applicant

RecordFirmDate
NORIAN SRS BONE CEMENT (P970010/S004)Synthes (Usa)2000-08-31
NORIAN SRS CEMENT (P970010/S002)Synthes (Usa)2000-04-28
NORIAN SRS CEMENT (P970010/S001)Synthes (Usa)1999-07-16
NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010)Synthes (Usa)1998-12-23