FDA.reportPublic FDA data

Golden Spike

Primary DI
00843511100742
Brand
Golden Spike
Company
OMNIA MEDICAL, LLC
Model
OM-TLS4545
Catalog number
OM-TLS4545
Device description
4.5 x 45mm Trauma Screw
Published
2020-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192096000Omnia Medical Trauma ScrewsOmnia Medical, LLC2020-02-27HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843511100742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511100742008435111007428435111007420843511100742

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3044134851customerservice@omniamedical.com

Regulatory Flags#

DUNS number
079467378
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843511102579Omnia Medical TiBrid™-TS09-0P-102207-102026-07-23
00843511102135Omnia Medical TiBrid™-TC08-0T-2707-72026-07-22
00843511102142Omnia Medical TiBrid™-TC08-0T-2708-708-0T-2708-72026-07-22
00843511102159Omnia Medical TiBrid™-TC08-0T-2709-708-0T-2709-72026-07-22
00843511102166Omnia Medical TiBrid™-TC08-0T-2710-708-0T-2710-72026-07-22
00843511102173Omnia Medical TiBrid™-TC08-0T-2711-708-0T-2711-72026-07-22
00843511102180Omnia Medical TiBrid™-TC08-0T-2712-708-0T-2712-72026-07-22
00843511102197Omnia Medical TiBrid™-TC08-0T-2713-708-0T-2713-72026-07-22
00843511102203Omnia Medical TiBrid™-TC08-0T-2714-708-0T-2714-72026-07-22
00843511102210Omnia Medical TiBrid™-TC08-0T-2715-708-0T-2715-72026-07-22
00843511102227Omnia Medical TiBrid™-TC08-0T-2716-708-0T-2716-72026-07-22
00843511102234Omnia Medical TiBrid™-TC08-0T-3107-708-0T-3107-72026-07-22
00843511102241Omnia Medical TiBrid™-TC08-0T-3108-708-0T-3108-72026-07-22
00843511102258Omnia Medical TiBrid™-TC08-0T-3109-708-0T-3109-72026-07-22
00843511102265Omnia Medical TiBrid™-TC08-0T-3110-708-0T-3110-72026-07-22
00843511102272Omnia Medical TiBrid™-TC08-0T-3111-708-0T-3111-72026-07-22
00843511102289Omnia Medical TiBrid™-TC08-0T-3112-708-0T-3112-72026-07-22
00843511102296Omnia Medical TiBrid™-TC08-0T-3113-708-0T-3113-72026-07-22
00843511102302Omnia Medical TiBrid™-TC08-0T-3114-708-0T-3114-72026-07-22
00843511102319Omnia Medical TiBrid™-TC08-0T-3115-708-0T-3115-72026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449033393A.L.P.S. mvX™Tyber Medical, LLCHWC2026-07-23
00196449033409A.L.P.S. mvX™Tyber Medical, LLCHWC2026-07-23
00841731140395ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140401ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140418ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140425ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140432ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140449ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140456ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140463ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140470ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140487ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140494ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140500ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140517ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140524ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140531ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140548ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140555ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140562ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140593ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140609ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140616ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140623ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140630ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140647ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140654ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140661ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140678ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140685ARTEMIS FUZEVILEX LLCHWC2026-07-22