FDA.reportPublic FDA data

COMPRESS / SRS INSTRUMENT

Primary DI
00880304566828
Brand
COMPRESS / SRS INSTRUMENT
Company
Biomet Orthopedics, LLC
Model
110004097
Catalog number
110004097
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
00880304566828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304566828008803045668288803045668280880304566828

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
00887868549236MULTI-DIRECTIONAL SCREW1312273081312273082022-11-14
00887868549243MULTI-DIRECTIONAL SCREW1312273091312273092022-11-14
00887868549250MULTI-DIRECTIONAL SCREW1312273101312273102022-11-14
00887868549267MULTI-DIRECTIONAL SCREW1312273111312273112022-11-14
00887868549274MULTI-DIRECTIONAL SCREW1312273121312273122022-11-14
00887868549281MULTI-DIRECTIONAL SCREW1312273131312273132022-11-14
00887868549298MULTI-DIRECTIONAL SCREW1312273141312273142022-11-14
00887868549304MULTI-DIRECTIONAL SCREW1312273151312273152022-11-14
00887868549311MULTI-DIRECTIONAL SCREW1312273161312273162022-11-14
00887868549328MULTI-DIRECTIONAL SCREW1312273181312273182022-11-14
00887868549335MULTI-DIRECTIONAL SCREW1312273201312273202022-11-14
00887868549342MULTI-DIRECTIONAL SCREW1312273221312273222022-11-14
00887868549359MULTI-DIRECTIONAL SCREW1312273241312273242022-11-14
00887868549366MULTI-DIRECTIONAL SCREW1312273261312273262022-11-14
00887868549373MULTI-DIRECTIONAL SCREW1312273281312273282022-11-14
00887868549380MULTI-DIRECTIONAL SCREW1312273301312273302022-11-14
00887868544699SMOOTH PEG1312270081312270082022-09-07
00887868544705SMOOTH PEG1312270091312270092022-09-07
00887868544712SMOOTH PEG1312270101312270102022-09-07
00887868544729SMOOTH PEG1312270111312270112022-09-07

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