FDA.reportPublic FDA data

N/A

Primary DI
00888233014151
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
SP-1998
Catalog number
SP-1998
Published
2020-06-16
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
GWOPlate, cranioplasty, preformed, alterable
GXRCOVER, BURR HOLE
HBWFASTENER, PLATE, CRANIOPLASTY
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2
GXRCover, Burr HoleNeurology2
HBWFastener, Plate, CranioplastyNeurology2
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121624000
K953385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121624000BIOMET MICROFIXATION NEURO PLATING SYSTEMBiomet Microfixation2012-10-12GWO
K953385000LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEMWalter Lorenz Surgical, Inc.1995-09-28JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888233014151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888233014151008882330141518882330141510888233014151

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small implantable plate/set of plates designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole; the material cannot be chemically degraded or absorbed by natural body processes. It is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover) and includes implant-grade metal; in addition to the plate(s) bone screws may be included.

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
00841036007621N/A01-037001-03702017-04-06
00841036007638N/A01-037101-03712017-04-06
00841036008819N/A01-145501-14552017-04-11
00841036159139N/A01-037601-03762017-04-06
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMWAL305WAL3052019-06-17
00888233078986VENAPAX XLVPX40002025-03-31
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00841036054229N/A915-2055915-20552015-10-11
00841036077969N/A915-2057915-20572015-10-15
00888233005371PECTUS SYSTEM01-390701-39072020-06-17
00888233011334RIBFIX BLU SYSTEM76-000376-00032020-06-18
00888233011587RIBFIX BLU SYSTEM76-119576-11952020-06-18
008882330161311.5MM SYSTEMSP-2335SP-23352020-06-16
008882330161862.0MM SYSTEMSP-2347SP-23472020-06-16
00888233018272TRAUMAONE SYSTEMSP-3228SP-32282020-06-17
00888233022385N/ASP-3139SP-31392020-06-17
00888233018296N/ASP-32302024-09-26
00888233069342STERNALOCK EZ115.101.04115.101.042024-05-29
00888233069359STERNALOCK EZ115.102.06115.102.062024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800089458912Leforte MMF SystemJeil Medical CorporationJEY2026-04-09
08800089458929Leforte MMF SystemJeil Medical CorporationJEY2026-04-09
G28436102NuCrani Large PlateNeurovention LLCGXR2022-06-21
G28440901KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
G28441001KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
07613327543032DELTAStryker Leibinger GmbH & Co. KGHBW2020-12-15
07613327543032DELTAStryker Leibinger GmbH & Co. KGGXR2020-12-15
07613327423648DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423648DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
07613327423655DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
07613327423655DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423662DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423662DELTAStryker Leibinger GmbH & Co. KGJEY2018-05-22
07613327423679DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
07613327423679DELTAStryker Leibinger GmbH & Co. KGJEY2018-05-22
07613327177527DELTAStryker Leibinger GmbH & Co. KGJEY2018-04-16
07613327177527DELTAStryker Leibinger GmbH & Co. KGGXR2018-04-16
07613327177534DELTAStryker Leibinger GmbH & Co. KGGXR2018-04-16
07613327177534DELTAStryker Leibinger GmbH & Co. KGHBW2018-04-16
07613327400953DELTAStryker Leibinger GmbH & Co. KGGXR2017-12-05
07613327400953DELTAStryker Leibinger GmbH & Co. KGJEY2017-12-05
08437006085076Cranial COVER “14 mm / 13 mm”NEOS SURGERY SLGXR2017-05-11
08437006085083Cranial COVER “10-12 mm”NEOS SURGERY SLGXR2017-05-11
07613327177510DELTAStryker Leibinger GmbH & Co. KGJEY2017-03-09
07613327177510DELTAStryker Leibinger GmbH & Co. KGHBW2017-03-09
07613327177541DELTAStryker Leibinger GmbH & Co. KGHBW2017-03-09
07613327177541DELTAStryker Leibinger GmbH & Co. KGGXR2017-03-09
08800000920658SMARTbuilder SystemOsstem Implant Co., Ltd.JEY2015-10-14
08800000920665SMARTbuilder SystemOsstem Implant Co., Ltd.JEY2015-10-14
08800000920672SMARTbuilder SystemOsstem Implant Co., Ltd.JEY2015-10-14