FDA.reportPublic FDA data

NA

Primary DI
04042409200038
Brand
NA
Company
aap Implantate AG
Model
SC 4030-48-2
Catalog number
SC 4030-48-2
Device description
Cannulated screw 4.0, short thread 15, L 48
Published
2016-08-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
K111316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111316000AAP CANNULATED SCREWSAap Implantate AG2011-07-20HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042409200038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042409200038040424092000384042409200038

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
328420633
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
04042409035845NAIP 0104-012018-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731132642REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132659REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132666REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132673REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132680REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132697REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132703REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132710REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132727REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132734REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132741REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132758REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132765REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132772REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132789REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132796REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132802REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132819REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132826REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132833REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132840REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132857REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132864REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132871REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132888REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132895REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132901REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132918REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132925REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132932REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03