OXFORD PERFORMANCE MATERIALS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3009582362	3009582362	OXFORD PERFORMANCE MATERIALS, INC.	1	N	2026-01-01	30 South Satellite Road South Windsor CT US 06074

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00810188325303	HTR-PEKK - PK627392	904-741-4400	fxjax-orders@biomet.com
00810188325372	HTR-PEKK - PK627399	904-741-4400	fxjax-orders@biomet.com
00810188325457	HTR-PEKK - PK627405	904-741-4400	fxjax-orders@biomet.com
00810188325464	HTR-PEKK - PK627407	904-741-4400	fxjax-orders@biomet.com
00810188325594	HTR-PEKK - PK627393-A	904-741-4400	fxjax-orders@biomet.com
00810188325624	HTR-PEKK - PK627420	904-741-4400	fxjax-orders@biomet.com
00810188325631	HTR-PEKK - PK627417	904-741-4400	fxjax-orders@biomet.com
00810188325679	HTR-PEKK - PK627424	904-741-4400	fxjax-orders@biomet.com

biomet.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
154639	1902930967	K190915	OsteoFab Suture Anchors	MBI	2019-07-03
154639	2061847500	K180064	OsteoFab Patient Specific Cranial Device	GXN	2018-07-27
154639	1046308941	K161052	OsteoFab Patient Specific Facial Device	KKY	2016-07-20
154639	1081994058	K142005	SpineFab Vertebral Body Replacement (VBR) System	MQP	2015-07-10
154639	2031537369	K133809	OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE	KKY	2014-07-28
154639	1679139628	K121818	OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE	GXN	2013-02-07
154639	1230844489
154639	1923763642
154639	1926728346

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GXN	2	2018-07-27
KKY	2	2016-07-20
MBI	1	2019-07-03
MQP	1	2015-07-10

PMN#

OsteoFab Suture Anchors
2019-07-03
Oxford Performance Materials, Inc.
OsteoFab Patient Specific Cranial Device
2018-07-27
Oxford Performance Materials, Inc.
OsteoFab Patient Specific Facial Device
2016-07-20
OXFORD PERFORMANCE MATERIALS, INC.

GUDID#

HTR-PEKK - PK627393-A
OXFORD PERFORMANCE MATERIALS, INC.
2026-09-25
HTR-PEKK - PK627424
OXFORD PERFORMANCE MATERIALS, INC.
2026-09-24
HTR-PEKK - PK627420
OXFORD PERFORMANCE MATERIALS, INC.
2026-09-21
HTR-PEKK - PK627417
OXFORD PERFORMANCE MATERIALS, INC.
2026-09-21
HTR-PEKK - PK627405
OXFORD PERFORMANCE MATERIALS, INC.
2026-09-04
HTR-PEKK - PK627407
OXFORD PERFORMANCE MATERIALS, INC.
2026-09-04
HTR-PEKK - PK627392
OXFORD PERFORMANCE MATERIALS, INC.
2026-08-26
HTR-PEKK - PK627399
OXFORD PERFORMANCE MATERIALS, INC.
2026-08-26
HTR-PEKK - PK627400
OXFORD PERFORMANCE MATERIALS, INC.
2026-08-26
HTR-PEKK - PK627394
OXFORD PERFORMANCE MATERIALS, INC.
2026-08-19
HTR-PEKK - PK627395
OXFORD PERFORMANCE MATERIALS, INC.
2026-08-19
HTR-PEKK - PK627391
OXFORD PERFORMANCE MATERIALS, INC.
2026-08-17
HTR-PEKK - PK627384
OXFORD PERFORMANCE MATERIALS, INC.
2026-08-07
HTR-PEKK - PK627385
OXFORD PERFORMANCE MATERIALS, INC.
2026-08-07
HTR-PEKK - PK627370
OXFORD PERFORMANCE MATERIALS, INC.
2026-08-03
HTR-PEKK - PK627373
OXFORD PERFORMANCE MATERIALS, INC.
2026-08-03
HTR-PEKK - PK627380
OXFORD PERFORMANCE MATERIALS, INC.
2026-08-03
HTR-PEKK - PK627379
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-31
OsteoFab Suture Anchor - OsteoFab Suture Anchor Inserter
OXFORD PERFORMANCE MATERIALS, INC.
2020-01-16
OsteoFab Suture Anchor - 2mm OsteoFab Suture Anchor Awl
OXFORD PERFORMANCE MATERIALS, INC.
2020-01-16
OsteoFab Suture Anchor - 3mm OsteoFab Suture Anchor Awl
OXFORD PERFORMANCE MATERIALS, INC.
2020-01-16
OsteoFab Suture Anchor - 4mm OsteoFab Suture Anchor Awl
OXFORD PERFORMANCE MATERIALS, INC.
2020-01-16
OsteoFab Suture Anchor - OsteoFab 4.5mm Suture Anchor
OXFORD PERFORMANCE MATERIALS, INC.
2020-01-16
OsteoFab Suture Anchor - OsteoFab 5.5mm Suture Anchor
OXFORD PERFORMANCE MATERIALS, INC.
2020-01-16
OsteoFab Suture Anchor - OsteoFab 6.5mm Suture Anchor
OXFORD PERFORMANCE MATERIALS, INC.
2020-01-16
HTR-PEKK - PK627374
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-28
HTR-PEKK - PK627357
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-27
HTR-PEKK - PK627344-A
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-23
HTR-PEKK - PK627372
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-23
HTR-PEKK - PK627371
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-20
HTR-PEKK - PK627343-B
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-20
HTR-PEKK - PK627368-A
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-20
HTR-PEKK - PK627327
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-17
HTR-PEKK - PK627359
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-14
HTR-PEKK - PK627369
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-14
HTR-PEKK - PK627347
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-13
HTR-PEKK - PK627360
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-13
HTR-PEKK - PK627365
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-13
HTR-PEKK - PK627354
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-10
HTR-PEKK - PK627364-A
OXFORD PERFORMANCE MATERIALS, INC.
2026-07-10

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