FDA.reportPublic FDA data

STERILE TRAC SYSTEM

Primary DI
00888233021951
Brand
STERILE TRAC SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
SP-3094
Catalog number
SP-3094
Published
2020-06-17
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
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972322000LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATESWalter Lorenz Surgical, Inc.1997-08-18JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888233021951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888233021951008882330219518882330219510888233021951

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00888233077200PECTUS BLU (TM)78-808278-80822024-09-30
00888233077224PECTUS BLU (TM)78-830078-83002024-09-30
00888233077231PECTUS BLU (TM)78-835078-83502024-09-30
00888233077248PECTUS BLU (TM)78-840078-84002024-09-30
00888233077255PECTUS BLU (TM)78-845078-84502024-09-30
00888233077279PECTUS BLU (TM)78-855078-85502024-09-30
00888233028776PECTUS BLU (TM)78-001078-00102022-02-09
00888233028783PECTUS BLU (TM)78-001178-00112022-02-09
00888233028790PECTUS BLU (TM)78-001278-00122022-02-09
00888233028806PECTUS BLU (TM)78-002078-00202022-02-09
00888233028813PECTUS BLU (TM)78-003078-00302022-02-09
00888233028837PECTUS BLU (TM)78-004078-00402022-02-09
00888233028844PECTUS BLU (TM)78-005078-00502022-02-09
00888233028851PECTUS BLU (TM)78-005178-00512022-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118154620LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
00888118154637LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
07613327694482DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
08904255300866ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300873ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300880ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300897ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300903ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300910ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300927ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300934ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300941ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301634ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301641ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301658ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301665ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301672ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301689ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301696ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301702ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301719ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301726ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301931ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301948ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301955ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301962ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301979ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301986ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301993ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20