FDA.reportPublic FDA data

COMPRESS / SRS INSTRUMENT

Primary DI
00880304566835
Brand
COMPRESS / SRS INSTRUMENT
Company
Biomet Orthopedics, LLC
Model
110004098
Catalog number
110004098
Published
2016-10-28
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
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123297000COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEMBiomet Manufactuting Corp.2012-11-20MBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304566835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304566835008803045668358803045668350880304566835

GMDN Terms#

Term, Definition table
TermDefinition
Humeral head prosthesis trial, reusableA copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2026-05-28
08033390002233SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002240SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002257SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050029SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050036SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390115667SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390115711SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121484SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121507SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121514SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121521SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121545SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121569SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121583SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121590SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121613SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121637SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121644SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121668SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121682SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121699SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121927SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121972SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121989SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122009SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122023SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122030SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122047SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390153119SMR ShoulderLIMACORPORATE SPAMBF2024-07-26