FDA.reportPublic FDA data

ANCHORAGE SYSTEM

Primary DI
00841036163853
Brand
ANCHORAGE SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
SP-3004
Catalog number
SP-3004
Published
2015-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OATImplant, endosseous, orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OATImplant, Endosseous, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063386000LORENZ ORTHODONTIC ANCHORAGE SYSTEMWalter Lorenz Surgical, Inc.2007-02-09OAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036163853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036163853008410361638538410361638530841036163853

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic anchor plateA small metallic plate that is implanted intraorally to serve as a temporary anchor for an orthodontic device (e.g., a spring). It is available in various sizes and lengths and is anchored to the jawbone with dedicated bone screws. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.

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
00888233025140N/A02-290202-29022020-06-26
00888233025157N/A02-290502-29052020-06-26
00888233025164N/A02-310102-31012020-06-26
00888233025171N/A02-310202-31022020-06-26
00888233025188N/A02-310502-31052020-06-26
00888233025195N/A02-311002-31102020-06-26
00888233025201N/A7014-32667014-32662020-06-26
00841036125844ALLOGENIX02-31012015-09-24
00841036125851ALLOGENIX02-31022015-09-24
00841036125868ALLOGENIX02-31052015-09-24
00841036125875ALLOGENIX02-31102015-09-24
00841036181468ALLOGENIX PLUS02-29022015-09-24
00841036181475ALLOGENIX PLUS02-29052015-09-24
00841036019112N/A02-008302-00832017-06-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J011302112000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-30
J011302114000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-30
J011302212000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-30
J011302214000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-30
J011302150000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-04
J011302250000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-04
04719873099689BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099696BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099702BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099719BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099757BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099764BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099771BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099788BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100057BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100064BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100071BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100088BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100248BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100255BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100262BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873093021BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873098736BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099580BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099597BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099603BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099610BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099627BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099634BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099641BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12