FDA.reportPublic FDA data

STERNALOCK 360 SYSTEM

Primary DI
00841036192136
Brand
STERNALOCK 360 SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
74-1192
Catalog number
74-1192
Published
2015-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151019000
K161896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151019000SternaLock® 360 Sternal Closure SystemBiomet Microfixation2015-11-03HRS
K161896000Biomet Microfixation Sternal Closure SystemBiomet Microfixation2016-08-02HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036192136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036192136008410361921368410361921360841036192136

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, reusableA non-powered device designed to lead a needle into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888233028875Pectus Blu (TM)78-880178-88012026-07-23
00888233028882Pectus Blu (TM)78-880278-88022026-07-23
00888233028899Pectus Blu (TM)78-880378-88032026-07-23
00888233086110Pectus Blu (TM)78-005378-00532026-07-23
00888233086127Pectus Blu (TM)78-005578-00552026-07-23
00888233086134Pectus Blu (TM)78-720078-72002026-07-23
00888233086141Pectus Blu (TM)78-725078-72502026-07-23
00888233086158Pectus Blu (TM)78-730078-73002026-07-23
00888233086165Pectus Blu (TM)78-735078-73502026-07-23
00888233086172Pectus Blu (TM)78-740078-74002026-07-23
00888233086189Pectus Blu (TM)78-745078-74502026-07-23
00888233086196Pectus Blu (TM)78-750078-75002026-07-23
00888233086202Pectus Blu (TM)78-755078-75502026-07-23
00888233086219Pectus Blu (TM)78-800178-80012026-07-23
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188132452Tools - TWFTrimed, INC.HRS2026-08-18
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00842188132247Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132254Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132261Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132445Tools - TWFTrimed, INC.HRS2026-08-17
00193982096274ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096298ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096311ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101909ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101923ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158323ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158378ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158620ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158675ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158729ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158774ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158828ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167615ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167660ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167714ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167769ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167813ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167868ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167912ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14