FDA.reportPublic FDA data

Universal Tendon Spacer

Primary DI
03700751502132
Brand
Universal Tendon Spacer
Company
ASKORN MEDICAL
Model
0232-01-00
Published
2025-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HXAProsthesis, Tendon, Passive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXAProsthesis, Tendon, PassiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243477000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243477000Universal Tendon SpacerAskorn Medical2025-01-10HXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700751502132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700751502132037007515021323700751502132

GMDN Terms#

Term, Definition table
TermDefinition
Tendon sheath regeneration implantA device intended to be implanted to temporarily aid growth of a new tendon sheath for tendon reconstruction. It is made of synthetic polymer (e.g., a silicone elastomer or polyester-reinforced silicone elastomer) and/or metal materials.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
289183779
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700751501456BE POD MEDIO AR PIED POIGNEE DROITE MINI AO0190 01 000190 01 002024-12-19
03700751500015MCL Retractor3000-022022-12-08
03700751500077Cannulated compressor PFCC0191-01-002022-12-08
03700751500275OSSKAR0197-00-002022-12-08
03700751501364Knee Positioning system1002-07-002022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B051427030Technical ProductsTECHNICAL PRODUCTS INCHXA2016-10-14
B051427040Technical ProductsTECHNICAL PRODUCTS INCHXA2016-10-14
B051427050Technical ProductsTECHNICAL PRODUCTS INCHXA2016-10-14
B051427060Technical ProductsTECHNICAL PRODUCTS INCHXA2016-10-14
00840420188373SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420188380SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420188397SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420188403SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420188410SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420197795SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420130662SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420130679SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420130686SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420130693SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420186782HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-07-29
00840420186799HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-07-29
00840420193018HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-07-29
00840420193100HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-07-29
M209100930TARA FEMORAL COMPONENT 55BIOPRO, INC.HXA2016-01-08
00840420132246HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-24
00840420132253HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-24
00840420132260HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-24
00840420132277HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-24
00840420132284HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-24
00840420132192HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420121851HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420121868HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420121875HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420121882HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420132147HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15