FDA.reportPublic FDA data

Comprehensive® SRS

Primary DI
00880304850392
Brand
Comprehensive® SRS
Company
Biomet Orthopedics, LLC
Model
110029938
Catalog number
110029938
Published
2017-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDCProsthesis, Elbow, Constrained, CementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153398000
K173411000
K223631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153398000Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp2016-02-03JDC
K173411000Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp2018-02-08PHX
K223631000Comprehensive Segmental Revision System(SRS)Biomet Orthopedics2023-07-12KWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304850392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304850392008803048503928803048503920880304850392

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated elbow humerus prosthesisA sterile implantable device designed to replace the distal humerus as part of an elbow joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097535678Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535692Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535715Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535739Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535753Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535777Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535791Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535814Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535838Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535852Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535876Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535890Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097534978Veritas rTSARestor3d, Inc.PHX2026-06-02
00840097534985Veritas rTSARestor3d, Inc.PHX2026-06-02
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWS2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWT2026-05-28
07613327668889Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
07613327668902Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
07613327668919Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
07613327603361REUNIONStryker GmbHKWS2024-10-01
07613327354331REUNIONStryker GmbHKWS2022-11-15
07613327354355REUNIONStryker GmbHKWS2022-11-15
07613327354805REUNIONStryker GmbHKWS2022-11-15
07613327354904REUNIONStryker GmbHKWS2022-11-15
07613327354935REUNIONStryker GmbHKWS2022-11-15
07613327354942REUNIONStryker GmbHKWS2022-11-15
07613327355024REUNIONStryker GmbHKWS2022-11-15
07613327355093REUNIONStryker GmbHKWS2022-11-15
07613327355109REUNIONStryker GmbHKWS2022-11-15