EXETER 0920-2-920

GUDID 04546540166715

2.5 STEM CENTRALIZER

Howmedica Osteonics Corp.

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

Primary Device ID	04546540166715
NIH Device Record Key	e74c3609-0994-4f15-823b-ae8cdd8ffd29
Commercial Distribution Status	In Commercial Distribution
Brand Name	EXETER
Version Model Number	0920-2-920
Catalog Number	0920-2-920
Company DUNS	058311945
Company Name	Howmedica Osteonics Corp.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter
Length	2.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540166715 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191414
Premarket Notification: K974054

FDA Product Code

JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-24

On-Brand Devices [EXETER]

07613327123845	EXETER STEM V40
07613327123791	EXETER STEM V40
07613327123777	EXETER STEM V40
07613327123753	EXETER STEM V40
07613327123746	EXETER STEM V40
07613327123739	EXETER STEM V40
07613327072396	RimFit Cup
07613327072341	RimFit Cup
07613327072334	RimFit Cup
07613327072327	RimFit Cup
07613327072310	RimFit Cup
07613327072303	RimFit Cup
07613327072297	RimFit Cup
07613327072280	RimFit Cup
07613327072273	RimFit Cup
07613327072266	RimFit Cup
07613327072259	RimFit Cup
07613327072242	RimFit Cup
07613327072235	RimFit Cup
07613327072228	RimFit Cup
07613327072211	RimFit Cup
07613327072204	RimFit Cup
07613327072198	RimFit Cup
07613327072181	RimFit Cup
07613327072174	RimFit Cup
07613327072167	RimFit Cup
07613327072150	RimFit Cup
07613327072143	RimFit Cup
07613327072136	RimFit Cup
07613327072129	RimFit Cup
07613327072112	RimFit Cup
07613327072105	RimFit Cup
07613327051087	2.5 I M PLUG
07613327045383	RimFit Cup
04546540509048	V40 Short femoral Stem
04546540167460	BONE PLUG
04546540167453	BONE PLUG
04546540167446	BONE PLUG
04546540167439	BONE PLUG
04546540167422	BONE PLUG
04546540167415	BONE PLUG
04546540167262	2.5 I M PLUG
04546540167255	2.5 I M PLUG
04546540167248	2.5 I M PLUG
04546540167231	2.5 I M PLUG
04546540167224	2.5 I M PLUG
04546540167200	2.5 I M PLUG
04546540167194	2.5 I M PLUG
04546540166715	2.5 STEM CENTRALIZER
04546540153968	Femoral head

Trademark Results [EXETER]

Mark Image Registration \| Serial	Company Trademark Application Date
EXETER 90559649 not registered Live/Pending	EQT AB 2021-03-04
EXETER 87768494 not registered Live/Pending	Exeter Finance LLC 2018-01-24
EXETER 87131287 not registered Dead/Abandoned	Reed, David 2016-08-08
EXETER 86652227 5402003 Live/Registered	DataPoint International, LLC 2015-06-04
EXETER 85911192 4610653 Live/Registered	DST Health Solutions, LLC 2013-04-22
EXETER 85708626 4621652 Live/Registered	DST Health Solutions, LLC 2012-08-21
EXETER 85612906 4877845 Dead/Cancelled	Exeter Finance Corp. 2012-05-01
EXETER 81038864 1038864 Dead/Cancelled	Scott & Fetzer Company, The 0000-00-00
EXETER 78070778 2765618 Live/Registered	XCaliber International Ltd., L.L.C. 2001-06-25
EXETER 77779827 3728400 Live/Registered	Pyramex Safety Products, LLC 2009-07-13
EXETER 77250908 3702155 Dead/Cancelled	BULOVA CORPORATION 2007-08-09
EXETER 76654364 not registered Dead/Abandoned	Strathmore Partners LP 2006-01-27