FDA.reportPublic FDA data

EASY-OUT EXTRACTOR, SMALL HUDSON

Primary DI
00848665040135
Brand
EASY-OUT EXTRACTOR, SMALL HUDSON
Company
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
Model
0815-100
Published
2023-01-31
Public version status
Update
Distribution status
Not 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
K014185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014185000AOS CANNULATED BONE SCREW SYSTEMAdvanced Orthopaedic Solutions, Inc.2002-02-13HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848665040135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848665040135008486650401358486650401350848665040135

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, single-useA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(310) 533-9966ATI_Regulatory@arthrex.com

Regulatory Flags#

DUNS number
117858154
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
00848665004021AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 1mmS1047-0192015-12-02
00848665004052AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 5mmS1047-0592015-12-02
00848665004083AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 10mmS1047-1092015-12-02
00848665004106AOS CAPTURED END CAP WITH POST 1mmS1048-0192015-12-02
00848665004823AOS END CAP, HUMERAL NAIL 2mmS1074-0202015-12-04
00848665004830AOS END CAP, HUMERAL NAIL 5mmS1074-0502015-12-05
00848665005332AOS END CAP, TIBIAL NAIL 5mmS1115-0502015-12-15
00848665005349AOS END CAP, TIBIAL NAIL 10mmS1115-1002015-12-15
00848665005356AOS END CAP, TIBIAL NAIL COMPRESSIONS11162015-12-15
00848665005363AOS SPACER, STATIC LOCKING TIBIAL NAILS11172015-10-14
00848665005745AOS FRACTURE REDUCTION SCREW HUMERAL NAILS11752015-10-12
00848665012521AOS END CAP, ANTEGRADE FEMORAL NAIL 5.0mmS1322-0052015-10-19
00848665012538AOS END CAP, ANTEGRADE FEMORAL NAIL 10.0mmS1322-0102015-12-18
00848665012545AOS END CAP, ANTEGRADE FEMORAL NAIL 15.0mmS1322-0152015-12-18
00848665012552AOS LOCKING END CAP, ANTEGRADE FEMORAL NAIL 0mmS13232015-12-18
00848665012569AOS END CAP, ANTEGRADE FEMORAL NAIL 0mmS13242015-12-18
00848665012576AOS SCREW SPACER/COMPRESSION BOLT S13262015-12-18
00848665013832AOS SET SCREW, A/R S10852015-12-04
00848665016536AOS END CAP, TIBIAL NAIL 5mm1115-0502015-10-26
00848665016543AOS END CAP, TIBIAL NAIL 10mm1115-1002015-10-26

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