FDA.reportPublic FDA data

Secure Screw 35mm

Primary DI
00857915007569
Brand
Secure Screw 35mm
Company
A.M. SURGICAL, INC.
Model
6300-11-35
Device description
Secure Screw 35mm
Published
2021-02-09
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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191771000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191771000SECURE ScrewA.M. Surgical, Inc.2019-10-16HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857915007566PackageGS15In Commercial Distribution
00857915007569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085791500756610857915007566
00857915007569008579150075698579150075690857915007569

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterile"A 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."

Contacts#

Phone, Email table
PhoneEmail
6319799777admin@amsurgical.com

Regulatory Flags#

DUNS number
160020087
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857915007767IM Nail Awl8900-202026-06-10
00857915007774Measuring Device8900-512026-06-10
00857915007804STRATOS Endoscopic Release System (GEN 2) Case of 55500-B2026-06-10
00857915007811Table Pad95012026-06-10
10857915007818Table Pads (5-pack)9501-B2026-06-10
20857915007815STRATOS Endo Release Kit (GEN 2) Case of 55500-K2026-06-10
00857915007705STRATOS (Gen2)5500-22026-06-05
00857915007033RetraBE Single - Gen 2 Depricated5500-SRB2026-06-04
00857915007743Hand Table95002026-06-04
00857915007750Endo ECTR Tray96002026-06-04
00857915007781Retra Uni Gen 1 (5-Pack)5500-UB2026-06-04
00857915007798Retra Uni Gen 1 Single5500-U2026-06-04
10857915007030RETRA Single - GEN 2 Depricated5500-RB2026-06-04
00857915007026Scope Adapter1200-012026-06-01
00857915007712Obturator9600-012026-06-01
00857915007729Cannula9600-022026-06-01
00857915007736Rasp9600-032026-06-01
00857915007699Locking Attachment9600-042026-05-20
00857915007132Stratos55002019-07-17
10857915007047RETRA5500-RN/A2026-05-20

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