FDA.reportPublic FDA data

NA

Primary DI
04042409450884
Brand
NA
Company
aap Implantate AG
Model
SH 7520-40-2
Device description
Cannulated Headless Bone Screw 7.5, L 140, TL 20 short, Titanium
Published
2024-09-27
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
K233008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233008000Cannulated Headless Bone ScrewsAap Implantate AG2024-06-05HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042409450884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042409450884040424094508844042409450884

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4930750190info@aap.de

Regulatory Flags#

DUNS number
328420633
Device count
1
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
04042409457203CHBSIC 2006-502026-10-16
04042409457289CHBSIC 2501-412026-10-16
04042409457302CHBSIC 2501-422026-10-16
04042409457326CHBSIC 2502-412026-10-16
04042409457340CHBSIC 2502-422026-10-16
04042409200021NASC 4030-46-2SC 4030-46-22016-08-18
04042409200038NASC 4030-48-2SC 4030-48-22016-08-18
04042409200045NASC 4030-50-2SC 4030-50-22016-08-18
04042409200076NASC 4050-10-2SC 4050-10-22016-08-18
04042409200083NASC 4050-12-2SC 4050-12-22016-08-18
04042409200090NASC 4050-14-2SC 4050-14-22016-08-18
04042409200106NASC 4050-16-2SC 4050-16-22016-08-18
04042409200120NASC 4050-18-2SC 4050-18-22016-08-18
04042409200151NASC 4050-20-2SC 4050-20-22016-08-18
04042409200168NASC 4050-22-2SC 4050-22-22016-08-18
04042409236990NASC 4030-46SC 4030-462016-08-18
04042409237003NASC 4030-48SC 4030-482016-08-18
04042409237010NASC 4030-50SC 4030-502016-08-18
04042409237027NASC 4030-55SC 4030-552016-08-18
04042409035807NAIP 0104-002018-02-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842078100011HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100028HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100035HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
20810152101418DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
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20810152101630DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101647DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101654DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101661DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13