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: PM622902 FDA UDI

Identifiers

Primary DI / UDI-DI: 00841036280178 FDA UDI
510(k) Number: K924935 FDA UDI
FDA Product Code: LZK FDA UDI
FWP FDA UDI
FZE FDA UDI
KKY FDA UDI
GMDN Term: Cranioplasty plate, non-alterable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.3550 FDA UDI
878.3680 FDA UDI
878.3500 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 cranioplasty plate, non-alterable implant designed to repair larger skull defects. It is typically preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull, and is usually 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 b3b5eefc-6282-46b1-a952-07b9a5efa5d2 35 fields · synced Jul 18, 2026