FDA.reportPublic FDA data

ExoShape Teno

Primary DI
M970110001062004
Brand
ExoShape Teno
Company
Medshape, Inc.
Model
1100-01-0620
Device description
EXOSHAPE-TENO Deployment Cartridge, 6mm x 20mm, Flat-Back
Published
2015-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
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
K101808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101808000SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNERMedshape Solutions2010-11-08HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M970110001062004PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
601306413
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M97015000009200Eclipse1500-00-09202017-02-16
M97015000004100Eclipse1500-00-04102017-05-19
M97015000004170Eclipse1500-00-04172017-02-16
M97015000005120Eclipse1500-00-05122017-05-19
M97015000005200Eclipse1500-00-05202017-05-19
M97015000006200Eclipse1500-00-06202017-05-19
M97015000007200Eclipse1500-00-07202017-05-19
M97015000008200Eclipse1500-00-08202017-05-19
00190446914020EF1DNE-1000-WFB32026-04-01
00190446914563EF1DNE-6000-0402026-04-01
00190446907374EF1911-07-00012026-03-31
00190446907381EF1911-07-00022026-03-31
00190446907404EF1912-07-00012026-03-31
00190446907411EF1912-07-00022026-03-31
00190446908333EF1913-07-00012026-03-31
00190446908340EF1913-07-00022026-03-31
00190446908357EF1913-07-00032026-03-31
00190446908364EF1913-07-00042026-03-31
00190446958987EF1911-07-00032026-03-31
00190446959533EF1911-07-00042026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613154320271MATTAStryker GmbHHWC2023-10-20
07613154320295MATTAStryker GmbHHWC2023-10-20
07613154320301MATTAStryker GmbHHWC2023-10-20
07613154320318MATTAStryker GmbHHWC2023-10-20
07613154320424MATTAStryker GmbHHWC2023-10-20
07613154320431MATTAStryker GmbHHWC2023-10-20
07613154320448MATTAStryker GmbHHWC2023-10-20
07613154320462MATTAStryker GmbHHWC2023-10-20
07613154320486MATTAStryker GmbHHWC2023-10-20
07613154320493MATTAStryker GmbHHWC2023-10-20
07613154320509MATTAStryker GmbHHWC2023-10-20
07613154320523MATTAStryker GmbHHWC2023-10-20
07613154320554MATTAStryker GmbHHWC2023-10-20
07613154320592MATTAStryker GmbHHWC2023-10-20
07613154320615MATTAStryker GmbHHWC2023-10-20
07613154320639MATTAStryker GmbHHWC2023-10-20
07613154320646MATTAStryker GmbHHWC2023-10-20
07613154320660MATTAStryker GmbHHWC2023-10-20
07613154320684MATTAStryker GmbHHWC2023-10-20
07613154320691MATTAStryker GmbHHWC2023-10-20
07613154320769MATTAStryker GmbHHWC2023-10-20
07613154320776MATTAStryker GmbHHWC2023-10-20
07613154320820MATTAStryker GmbHHWC2023-10-20
07613154320837MATTAStryker GmbHHWC2023-10-20
07613154320844MATTAStryker GmbHHWC2023-10-20
07613154320851MATTAStryker GmbHHWC2023-10-20
07613154320868MATTAStryker GmbHHWC2023-10-20
07613154320875MATTAStryker GmbHHWC2023-10-20
07613154320899MATTAStryker GmbHHWC2023-10-20
07613154320912MATTAStryker GmbHHWC2023-10-20