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
00810188326003	HTR-PEKK - PK627454	904-741-4400	fxjax-orders@biomet.com
00810188326010	HTR-PEKK - PK627460	904-741-4400	fxjax-orders@biomet.com
00810188326027	HTR-PEKK - PK627461	904-741-4400	fxjax-orders@biomet.com
00810188326065	HTR-PEKK - PK627459	904-741-4400	fxjax-orders@biomet.com
00810188326072	HTR-PEKK - PK627465	904-741-4400	fxjax-orders@biomet.com
00810188326089	HTR-PEKK - PK627446	904-741-4400	fxjax-orders@biomet.com
00810188326096	HTR-PEKK - PK627466	904-741-4400	fxjax-orders@biomet.com
00810188326102	HTR-PEKK - PK627467	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 - PK627459
OXFORD PERFORMANCE MATERIALS, INC.
2026-11-05
HTR-PEKK - PK627466
OXFORD PERFORMANCE MATERIALS, INC.
2026-11-05
HTR-PEKK - PK627460
OXFORD PERFORMANCE MATERIALS, INC.
2026-11-04
HTR-PEKK - PK627461
OXFORD PERFORMANCE MATERIALS, INC.
2026-11-03
HTR-PEKK - PK627465
OXFORD PERFORMANCE MATERIALS, INC.
2026-11-03
HTR-PEKK - PK627446
OXFORD PERFORMANCE MATERIALS, INC.
2026-11-04
HTR-PEKK - PK627467
OXFORD PERFORMANCE MATERIALS, INC.
2026-11-04
HTR-PEKK - PK627454
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-30
HTR-PEKK - PK627464
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-30
HTR-PEKK - PK627462
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-30
HTR-PEKK - PK627457
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-26
HTR-PEKK - PK627422
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-22
HTR-PEKK - PK627453
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-21
HTR-PEKK - PK627455
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-21
HTR-PEKK - PK627456
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-21
HTR-PEKK - PK627439
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-20
HTR-PEKK - PK627448
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-20
HTR-PEKK - PK627451
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-20
HTR-PEKK - PK627452
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-19
HTR-PEKK - PK627449
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-16
HTR-PEKK - PK627442
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-14
HTR-PEKK - PK627447
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-14
HTR-PEKK - PK627443
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-13
HTR-PEKK - PK627412
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-12
HTR-PEKK - PK627434
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-12
HTR-PEKK - PK627444
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-12
HTR-PEKK - PK627445
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-12
HTR-PEKK - PK627440
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-09
HTR-PEKK - PK627433
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-08
HTR-PEKK - PK627348
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-07
HTR-PEKK - PK627048-A
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-07
HTR-PEKK - PK627419
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-06
HTR-PEKK - PK627426
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-06
HTR-PEKK - PK627425
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-05
HTR-PEKK - PK627435
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-05
HTR-PEKK - PK627436
OXFORD PERFORMANCE MATERIALS, INC.
2026-10-05
HTR-PEKK - PK627388-A
OXFORD PERFORMANCE MATERIALS, INC.
2026-09-30
HTR-PEKK - PK627416
OXFORD PERFORMANCE MATERIALS, INC.
2026-09-29
HTR-PEKK - PK627418
OXFORD PERFORMANCE MATERIALS, INC.
2026-09-28
HTR-PEKK - PK627393-A
OXFORD PERFORMANCE MATERIALS, INC.
2026-09-25

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