FDA.reportPublic FDA data

Jones Screw Tap, 5.5mm

Primary DI
00840118114486
Brand
Jones Screw Tap, 5.5mm
Company
FLOWER ORTHOPEDICS CORPORATION
Model
FJS 955
Published
2018-09-20
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
HWXTap, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118114486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118114486008401181144868401181144860840118114486

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, single-use, sterileA sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078790947
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840118126199Active CompressionOTP0552025-12-01
00840118126298Active CompressionSHADP2025-12-01
00840118126526Active CompressionOC701202025-12-01
00840118116800ZERO Profile Interlocking Cortex Screw, 3.5mm x 10mm, T15, Flex-Thread™8525-10-S2021-03-19
00840118116817ZERO Profile Interlocking Cortex Screw, 3.5mm x 12mm, T15, Flex-Thread™8525-12-S2021-03-19
00840118116824ZERO Profile Interlocking Cortex Screw, 3.5mm x 14mm, T15, Flex-Thread™8525-14-S2021-03-19
00840118116831ZERO Profile Interlocking Cortex Screw, 3.5mm x 16mm, T15, Flex-Thread™8525-16-S2021-03-19
00840118116848ZERO Profile Interlocking Cortex Screw, 3.5mm x 18mm, T15, Flex-Thread™8525-18-S2021-03-19
00840118116855ZERO Profile Interlocking Cortex Screw, 3.5mm x 20mm, T15, Flex-Thread™8525-20-S2021-03-19
00840118116862ZERO Profile Interlocking Cortex Screw, 3.5mm x 22mm, T15, Flex-Thread™8525-22-S2021-03-19
00840118116879ZERO Profile Interlocking Cortex Screw, 3.5mm x 24mm, T15, Flex-Thread™8525-24-S2021-03-19
00840118116886ZERO Profile Interlocking Cortex Screw, 3.5mm x 26mm, T15, Flex-Thread™8525-26-S2021-03-19
00840118116893ZERO Profile Interlocking Cortex Screw, 3.5mm x 28mm, T15, Flex-Thread™8525-28-S2021-03-19
00840118116909ZERO Profile Interlocking Cortex Screw, 3.5mm x 30mm, T15, Flex-Thread™8525-30-S2021-03-19
00840118116916ZERO Profile Interlocking Cortex Screw, 3.5mm x 32mm, T15, Flex-Thread™8525-32-S2021-03-19
00840118116923ZERO Profile Interlocking Cortex Screw, 3.5mm x 34mm, T15, Flex-Thread™8525-34-S2021-03-19
00840118116930ZERO Profile Interlocking Cortex Screw, 3.5mm x 36mm, T15, Flex-Thread™8525-36-S2021-03-19
00840118116947ZERO Profile Interlocking Cortex Screw, 3.5mm x 38mm, T15, Flex-Thread™8525-38-S2021-03-19
00840118116954ZERO Profile Interlocking Cortex Screw, 3.5mm x 40mm, T15, Flex-Thread™8525-40-S2021-03-19
00840118116961ZERO Profile Interlocking Cortex Screw, 3.5mm x 42mm, T15, Flex-Thread™8525-42-S2021-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10885862634351EquinoxeExactech, Inc.HWX2026-04-28
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
G079C5020000950Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001000Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001050Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
07640450868374PERLA ®SpineArt SAHWX2025-11-10
07640450868381PERLA ®SpineArt SAHWX2025-11-10
08800308480564INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480571INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480588INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480595INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480601INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
09120125220136Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220143Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220150Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220167Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220174Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220181Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220198Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220204Shark Screw® tapsurgebright GmbHHWX2025-09-16
07640177820464Neo Medical Pedicle Screw SystemNeo Medical SAHWX2023-01-25