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
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707047Signature ONE Software PackageOrthosoft IncMBF2026-07-10
00889024701540Identity® Shoulder SystemZimmer, Inc.MBF2026-06-10
00889024702127Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702134Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702141Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702158Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702165Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702172Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702189Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702196Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702202Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024704916Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704923Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704930Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704947Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704954Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704961Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704978Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704985Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704992Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705005Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705012Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705029Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705036Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705043Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705050Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705067Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705074Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705081Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705098Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10