FDA.reportPublic FDA data

OrthoMesh

Primary DI
10886982256157
Brand
OrthoMesh
Company
Synthes GmbH
Model
851.712.97S
Catalog number
85171297S
Device description
ORTHOMESH RESORBABLE STRAIGHT ROW 100MMX100MMX0.5MM-STERILE
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073115000ORTHOMESHSynthes (Usa)2008-07-15HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982256157PrimaryGS10
H67985171297S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698225615710886982256157

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, bioabsorbableA non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature043 Degrees Celsius
Handling Environment Temperature0110 Degrees Fahrenheit
Special Storage Condition, Specify00.
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112599275TriLEAP04.900.251049002512025-03-20
00810112599169TriLEAP04.900.240049002402025-03-18
00810112599763TriLEAP03.900.407039004072025-03-18
00810112599176TriLEAP04.900.241049002412025-03-17
00810112599183TriLEAP04.900.242049002422025-03-17
00810112599190TriLEAP04.900.243049002432025-03-17
00810112599206TriLEAP04.900.244049002442025-03-17
00810112599213TriLEAP04.900.245049002452025-03-17
00810112599220TriLEAP04.900.246049002462025-03-17
00810112599237TriLEAP04.900.247049002472025-03-17
00810112599244TriLEAP04.900.248049002482025-03-17
00810112599251TriLEAP04.900.249049002492025-03-17
00810112599268TriLEAP04.900.250049002502025-03-17
00810112592467TriLeap Lower Etremity Anatomic Plating System60.900.307609003072024-02-23
00810112592528TriLeap Lower Extremity Anatomic Plating03.900.311039003112024-02-23
00810112592566TriLeap Lower Etremity Anatomic Plating System03.900.332039003322024-02-23
00810112597035TriLeap Lower Extremity Plating System04.900.057049000572024-02-21
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986482594CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-23
00810112599275TriLEAPSynthes GmbHHRS2025-03-20
00810112599275TriLEAPSynthes GmbHHWC2025-03-20
00810112599169TriLEAPSynthes GmbHHWC2025-03-18
00810112599169TriLEAPSynthes GmbHHRS2025-03-18
00810112599176TriLEAPSynthes GmbHHWC2025-03-17
00810112599176TriLEAPSynthes GmbHHRS2025-03-17
00810112599183TriLEAPSynthes GmbHHWC2025-03-17
00810112599183TriLEAPSynthes GmbHHRS2025-03-17
00810112599190TriLEAPSynthes GmbHHWC2025-03-17
00810112599190TriLEAPSynthes GmbHHRS2025-03-17
00810112599206TriLEAPSynthes GmbHHWC2025-03-17
00810112599206TriLEAPSynthes GmbHHRS2025-03-17
00810112599213TriLEAPSynthes GmbHHRS2025-03-17
00810112599213TriLEAPSynthes GmbHHWC2025-03-17
00810112599220TriLEAPSynthes GmbHHWC2025-03-17
00810112599220TriLEAPSynthes GmbHHRS2025-03-17
00810112599237TriLEAPSynthes GmbHHWC2025-03-17
00810112599237TriLEAPSynthes GmbHHRS2025-03-17
00810112599244TriLEAPSynthes GmbHHWC2025-03-17
00810112599244TriLEAPSynthes GmbHHRS2025-03-17
00810112599251TriLEAPSynthes GmbHHWC2025-03-17
00810112599251TriLEAPSynthes GmbHHRS2025-03-17
00810112599268TriLEAPSynthes GmbHHWC2025-03-17
00810112599268TriLEAPSynthes GmbHHRS2025-03-17
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23