FDA.reportPublic FDA data

AO Countersink, Large, Cannulated

Primary DI
00840118113878
Brand
AO Countersink, Large, Cannulated
Company
FLOWER ORTHOPEDICS CORPORATION
Model
FCS 913
Device description
implants for orthopedic bone fixation
Published
2018-06-12
Public version status
New
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
HWWCountersink

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118113878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118113878008401181138788401181138780840118113878

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078790947
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
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
00841731146854TITANEX VILEX LLCHWW2026-05-15
00841731146878TITANEX VILEX LLCHWW2026-05-15
00841731146892TITANEX VILEX LLCHWW2026-05-15
00841731146915TITANEX VILEX LLCHWW2026-05-15
00841731146939TITANEX VILEX LLCHWW2026-05-15
03700569679170Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
03700569679187Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
00810211043945Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043952Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043969Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043976Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043983Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043990Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044003Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044010Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
08437019739430WasherCap™ Countersink 11 mmABANZA TECNOMED SL.HWW2026-03-30
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWW2026-03-30
05055662971576ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWW2026-03-04
00841731135308Redemption VILEX LLCHWW2026-01-12
00840118126250Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
00840118126267Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
00889795141330Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.HWW2025-11-19
00194613014766MSI Precision Specialty InstrumentsMed Saver, Inc.HWW2025-08-01
00885556896464TRIGEN MAXSmith & Nephew, Inc.HWW2025-05-07
04042409452741NAaap Implantate AGHWW2025-02-26
04042409452789NAaap Implantate AGHWW2025-02-26
04042409452826NAaap Implantate AGHWW2025-02-26
04042409452864NAaap Implantate AGHWW2025-02-26
10888277373754MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
10888277379152MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21