FDA.reportPublic FDA data

Anatomic Distal Fibula Plate, 5 Holes, Left

Primary DI
00840118109192
Brand
Anatomic Distal Fibula Plate, 5 Holes, Left
Company
FLOWER ORTHOPEDICS CORPORATION
Model
DLF 105
Device description
Implants for orthopedic bone fixation, compatible with 2.7mm/3.5mm/4.0mm Screws.
Published
2015-09-15
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133102000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133102000FLOWER ANKLE PLATING SETFlower Orthopedics Corporation2013-11-18HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118109192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118109192008401181091928401181091920840118109192

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8777788587info@flowerortho.com

Regulatory Flags#

DUNS number
078790947
Device count
1
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
07901125620742Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620759Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620773Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620780Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620797Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620803Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620810Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620827Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620834Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620841Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620858Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620865Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620872Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620889Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620896Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620902Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
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07901125620926Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620933Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620940Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620957Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620964Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
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07901125620988Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620537Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620544Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620551Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620568Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
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07901125620711Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26