Htr-Pmi

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name: HTR-PMI FDA UDI
Generic Name: Cranioplasty plate, non-alterable FDA UDI
Model / Reference: PM619804 FDA UDI

Identifiers

Primary DI / UDI-DI: 00841036237110 FDA UDI
510(k) Number: K924935 FDA UDI
FDA Product Code: LZK FDA UDI
KKY FDA UDI
FZE FDA UDI
FWP FDA UDI
GMDN Term: Cranioplasty plate, non-alterable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.3550 FDA UDI
878.3500 FDA UDI
878.3680 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cranioplasty plate, non-alterable

The HTR-PMI is a preformed cranioplasty plate designed for repairing larger skull defects that can be caused by injury, surgical intervention, congenital anomaly, or disease. This implantable shield is typically made of sheets of material such as stainless steel, vitallium, titanium (Ti), or plastic resins and is fixed to the intact cranial bones using screws and/or other fasteners.

Similar devices

Also classified as Cranioplasty plate, non-alterable.

AccuShape® — Medcad · Class II
CranioFit — Bioplate, Inc. · Class II
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) — Kontour(Xi'An) Medical Technology Co., Ltd. · Class II
CranioFit — Bioplate, Inc. · Class II
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) — Kontour(Xi'An) Medical Technology Co., Ltd. · Class II
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) — Kontour(Xi'An) Medical Technology Co., Ltd. · Class II
CranioFit — Bioplate, Inc. · Class II
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) — Kontour(Xi'An) Medical Technology Co., Ltd. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biomet Microfixation, Inc

Sources (1)

FDA UDI 5d48626e-48f8-4e8f-9bcb-aae9ea9ba340 35 fields · synced Jul 9, 2026