FDA.report

Trabecular Metal Reverse Plus™

Primary DI
00889024489561
Brand
Trabecular Metal Reverse Plus™
Company
Zimmer, Inc.
Model
00-4363-040-25
Catalog number
00-4363-040-25
Published
2019-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Product Code Classifications

CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2

Premarket Submissions

SubmissionSupplement
K172767000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K172767000Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.2017-11-30PHX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024489561PrimaryGS10

GMDN Terms

TermDefinition
Reverse shoulder prosthesis headA sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to articulate with the reverse shoulder cup.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags

DUNS number
056038268
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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