FDA.reportPublic FDA data

11mm Conical Tap

Primary DI
00847538001297
Brand
11mm Conical Tap
Company
SYMMETRY MEDICAL INC.
Model
12-009-000
Catalog number
2709-01-013;00-9986-010-24;430033
Device description
11mm Conical Tap
Published
2022-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00847538001297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847538001297008475380012978475380012970847538001297

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079881212
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847538007787Component Impactor10-016-400-15002011-03-0372022-05-17
00847538005479Patella Caliper802-01-1122025-12-10
00847538007930Bone Hook - Small10-257-000803-61-0252025-10-20
00847538008654HP Extraction Standard Removal Case87-10082011-03-0482023-11-28
00847538015256Flexible Osteotome System with Radel Case30-005-0002709-04-000; 30-005-000-15002023-07-17
00847538019179Femoral Tray30-037-4002709-01-000; 30-037-400-15002023-07-17
00817766026423GLOBAL UNITE™ Short Stem Instrumentation2236002112021-09-01
00847538010558Tuning Fork12-070-0002011-03-0302022-05-17
00847538010565MBT Tray/Sleeve Separator12-071-4002011-03-0532022-05-17
00847538010572Sleeve Removal Tool12-072-0002011-03-0312022-05-17
00847538005431Extraction Screw, 8 MM12-010-000-15002011-03-0422022-05-13
00847538010527Head Extractor12-063-0002500-00-7792022-05-13
00847538010534Forked Stem Extractor Wide12-065-0002500-00-7812022-05-13
00847538010541Forked Stem Extractor Narrow12-067-0002500-00-7802022-05-13
00847538015751Adapter Slaphammer to Locking Pliers12-053-000-15002011-03-0462022-05-13
00847538015768Stem Trial Remover Slaphammer adapter12-054-000-15002011-03-0472022-05-13
00847538015775Tibial Component Extractor74-591-000-15002011-03-0452022-05-13
00847538007916Head Removal Fork10-246-4002500-00-7762022-05-12
00847538001471T-Bar Stem Extractor10-062-0002709-05-003;00-9986-040-122022-05-11
00847538010473Driver Shaft w/Slaphammer w/Hudson Connector12-048-0002709-05-0012022-05-11

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
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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