FDA.reportPublic FDA data

STANMORE HIP SYSTEM

Primary DI
00880304257283
Brand
STANMORE HIP SYSTEM
Company
Biomet Orthopedics, LLC
Model
164240
Catalog number
164240
Published
2015-10-24
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
JDGProsthesis, hip, femoral component, cemented, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDGProsthesis, Hip, Femoral Component, Cemented, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942028000RX90 FEMORAL COMPONENTBiomet, Inc.1994-09-19JDG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304257283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304257283008803042572838803042572830880304257283

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement spacerA prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

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Primary DI, Brand, Company table
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07613327123739EXETERHowmedica Osteonics Corp.JDG2018-05-03
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07613327123753EXETERHowmedica Osteonics Corp.JDG2018-05-03
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