FDA.reportPublic FDA data

3.5mm Broken Screw Removal System-Sterile

Primary DI
B562KITBSK3500
Brand
3.5mm Broken Screw Removal System-Sterile
Company
Wishbone Medical, Inc.
Model
KIT-BSK-350
Published
2019-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B562KITBSK3500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Screw-extraction orthopaedic reamer, single-useA sterile surgical tool designed for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. It is in the form of a thin hollow metal shaft, with saw teeth at the cutting edge and a conical thread within the lumen. The device is rotated around the screw shaft to remove a thin layer of bone, either by a surgical power tool or a manual handle, until the internal thread grips the screw for removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062355158
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B562PK301ELB1600K-WirePK-301-ELB1602023-03-16
B562PK301ELB2000K-WirePK-301-ELB2002023-03-16
B562PK301EXT1250K-WirePK-301-ELB2002023-03-16
B56213904001220S00WishBone K-Wire System13-904-001220S-013-904-001220S-02022-07-18
B56213904001220S10WishBone K-Wire System13-904-001220S-113-904-001220S-12022-07-18
B56213904001620S00WishBone K-Wire System13-904-001620S-013-904-001620S-02022-07-18
B56213904001620S10WishBone K-Wire System13-904-001620S-113-904-001620S-12022-07-18
B56213904002020S00WishBone K-Wire System13-904-002020S-013-904-002020S-02022-07-18
B56213904002020S10WishBone K-Wire System13-904-002020S-113-904-002020S-12022-07-18
B56213904002520S00WishBone K-Wire System13-904-002520S-013-904-002520S-02022-07-18
B56213904002520S10WishBone K-Wire System13-904-002520S-113-904-002520S-12022-07-18
B562PKKWELB0WishBone K-Wire SystemPK-KWELBPK-KWELB2020-12-02
B562PKKWELBUS0WishBone K-Wire SystemPK-KWELB-USPK-KWELB2020-12-02
B562PKKWEXT0WishBone K-Wire SystemPK-KWEXTPK-KWEXT2020-12-02
B562PKKWEXTUS0WishBone K-Wire SystemPK-KWEXT-USPK-KWEXT2020-12-02
B562KITKWIEXSML0Pediatric Extremity Combo K-Wire System-SMALLKIT-KWI-EXSML2019-03-28
B562KITKWIELBOW0Pediatric Elbow Combo K-Wire SystemKIT-KWI-ELBOW2019-03-18
B562KITKWIEXLAR0Pediatric Extremity Combo K-Wire SystemKIT-KWI-EXLAR2019-03-19
B562KITKWIEXMED0Pediatric Extremity Combo K-Wire SystemKIT-KWI-EXMED2019-03-19
B562KITKWILBONE0Pediatric Long Bone Combo K-Wire SystemKIT-KWI-LBONE2019-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
10705034535364NADEPUY SPINE, LLCHWB2019-02-12
10705034535821NADEPUY SPINE, LLCHWB2019-02-12
10705034533650NADEPUY SPINE, LLCHWB2019-01-16
10705034533667NADEPUY SPINE, LLCHWB2019-01-16
10705034533674NADEPUY SPINE, LLCHWB2019-01-16
10705034533681NADEPUY SPINE, LLCHWB2019-01-16
10705034533698NADEPUY SPINE, LLCHWB2019-01-16
10705034533704NADEPUY SPINE, LLCHWB2019-01-16
10705034533711NADEPUY SPINE, LLCHWB2019-01-16
10705034533728NADEPUY SPINE, LLCHWB2019-01-16
10705034533735NADEPUY SPINE, LLCHWB2019-01-16
10705034533742NADEPUY SPINE, LLCHWB2019-01-16
10705034534060NADEPUY SPINE, LLCHWB2019-01-16
10705034534152NADEPUY SPINE, LLCHWB2019-01-16
10705034534169NADEPUY SPINE, LLCHWB2019-01-16
10705034497754N/ADEPUY SPINE, LLCHWB2018-11-05
10603295080763NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295087861NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295087878NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295090595GLOBAL APDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295090649GLOBAL APDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295156017RECLAIMDEPUY (IRELAND)HWB2018-09-24
10603295159087LPSDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295171669S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295171676S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295171683S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295178408NADEPUY (IRELAND)HWB2018-09-24
10603295181651S-ROM NOILESDEPUY (IRELAND)HWB2018-09-24
10603295248439SPECIALISTDEPUY (IRELAND)HWB2018-09-24