FDA.reportPublic FDA data

NA

Primary DI
EATO4453369
Brand
NA
Company
aap Implantate AG
Model
445336
Catalog number
445336
Device description
Cannulated screw 4.5, L 36, full thread
Published
2016-10-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
EATO4453369PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
328420633
Device count
1
DM exempt
true
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
04042409035807NAIP 0104-002018-02-28
04042409035845NAIP 0104-012018-02-28
04042409002939NAIP 8403-002018-02-28
04042409036170NAIP 2505-002018-02-28
04042409207273NAIP 8405-002018-02-28
04042409228995NAIP 8405-502018-02-28
04042409363337NAIP 2506-002018-02-28
04042409387555LOQTEQ®IU 8166-042018-02-28
04042409202711LOQTEQ®PG 3555-04-2PG 3555-04-22016-08-18
04042409202728LOQTEQ®PG 3555-05-2PG 3555-05-22016-08-18
04042409202735LOQTEQ®PG 3555-06-2PG 3555-06-22016-08-18
04042409202742LOQTEQ®PG 3555-07-2PG 3555-07-22016-08-18
04042409202766LOQTEQ®PG 3555-08-2PG 3555-08-22016-08-18
04042409202773LOQTEQ®PG 3555-09-2PG 3555-09-22016-08-18
04042409202797LOQTEQ®PG 3555-10-2PG 3555-10-22016-08-18
04042409202803LOQTEQ®PG 3555-11-2PG 3555-11-22016-08-18
04042409202810LOQTEQ®PG 3555-12-2PG 3555-12-22016-08-18
04042409202827LOQTEQ®PG 3555-14-2PG 3555-14-22016-08-18
04042409202834LOQTEQ®PG 3555-16-2PG 3555-16-22016-08-18
04042409202841LOQTEQ®PG 3555-18-2PG 3555-18-22016-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01