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Bioplate, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 570 S. Melrose St., Placentia, CA, 92870
Website: bioplate.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 888-246-7528
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000518793
DUNS Number: 838734093

Catalogue (1156)

Page 15 of 24

Device	Model / Reference	Registries	Class	Status
Bioplate®	81-3041[US]	FDA UDI	Class II	Active
Bioplate®	81-1043	FDA UDI	Class II	Active
Bioplate®	SCD8-05-05	FDA UDI	Class II	Active
Bioplate®	SCE4-07-05	FDA UDI	Class II	Active
Bioplate®	81-5729-CP	FDA UDI	Class II	Active
Bioplate®	81-2054[US]	FDA UDI	Class II	Active
Bioplate®	P2TB-05-15	FDA UDI	Class II	Active
Bioplate®	P2BX-04-10	FDA UDI	Class II	Active
Bioplate®	81-3140[US]	FDA UDI	Class II	Active
Bioplate®	81-3422	FDA UDI	Class I	Active
Bioplate®	81-3412	FDA UDI	Class I	Active
Bioplate®	SCD8-03-01	FDA UDI	Class II	Active
Bioplate®	81-5721-CP	FDA UDI	Class II	Active
Bioplate®	81-2008	FDA UDI	Class II	Active
Bioplate®	81-3494	FDA UDI	Class II	Active
Bioplate®	CPS2-50-SALE	FDA UDI	Class I	Active
Bioplate®	81-3041	FDA UDI	Class II	Active
Bioplate®	81-2010	FDA UDI	Class II	Active
Bioplate®	CPS2-12	FDA UDI	Class I	Active
Bioplate®	81-3373	FDA UDI	Class II	Active
Bioplate®	81-3036[US]	FDA UDI	Class II	Active
Bioplate®	CRSH-50-SALE	FDA UDI	Class I	Active
Bioplate®	81-3086	FDA UDI	Class I	Active
Bioplate®	81-3072	FDA UDI	Class I	Active
Bioplate®	81-3048	FDA UDI	Class II	Active
Bioplate®	81-3340	FDA UDI	Class I	Active
Bioplate®	81-3411	FDA UDI	Class I	Active
Bioplate®	81-2002-CP	FDA UDI	Class II	Active
Bioplate®	81-2027	FDA UDI	Class I	Active
Bioplate®	81-3063	FDA UDI	Class I	Active
Bioplate®	CPS4-50	FDA UDI	Class I	Active
Bioplate®	81-3300	FDA UDI	Class II	Active
Bioplate®	81-5791	FDA UDI	Class II	Active
Bioplate®	DBP8-10	FDA UDI	Class I	Active
Bioplate®	81-3073	FDA UDI	Class I	Active
Bioplate®	81-3579	FDA UDI	Class II	Active
Bioplate®	81-3498	FDA UDI	Class II	Unknown
Bioplate®	SCR4-13-05	FDA UDI	Class II	Active
CranioFit	KT-T6L14H2	FDA UDI	Class II	Active
CranioFit	KT-T4L6H1	FDA UDI	Class II	Active
CranioFit	KT-T3L15H2	FDA UDI	Class II	Active
Bioplate®	SCE2-08-05	FDA UDI	Class II	Active
CranioFit	KT-T3L18H1	FDA UDI	Class II	Active
Bioplate®	81-2046-CP	FDA UDI	Class II	Active
Bioplate®	81-3053-CP	FDA UDI	Class II	Active
Bioplate®	81-3576	FDA UDI	Class II	Active
Bioplate®	SCE2-12-05	FDA UDI	Class II	Active
Bioplate®	81-3048[US]	FDA UDI	Class II	Active
Bioplate®	81-2015	FDA UDI	Class II	Active
CranioFit	KT-T9L11H2	FDA UDI	Class II	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 31, 2010	Z-0143-2012	—	terminated	There is potential defect in seal of the sterile barrier containing the device.
Sep 12, 2006	Z-0043-2007	—	terminated	Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.