FDA.reportPublic FDA data

NA

Primary DI
H98129199201S0
Brand
NA
Company
Synthes GmbH
Model
291.992.01S
Catalog number
29199201S
Device description
1.0MM CABLE WITH CRIMP DOUBLE LEAD 470MM-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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDQCERCLAGE, FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002110000SPL CRIMP SYSTEMPioneer Surgical Technology2000-10-06JDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034764047PrimaryGS10
H98129199201S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503476404710705034764047

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
486711679
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982198266NA391.73391732016-12-31
10886982312259NA60.133.200601332002022-04-12
10886982312266NA60.133.300601333002022-06-17
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07899258654867Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654874Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
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07899258654898Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
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07899258654928Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
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07899258655017Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258655024Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
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07899258657738Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258657745Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
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07899258657776Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258657790Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
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07899258657837Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17