Identity
- Trade Name
- HTR-PMI FDA UDI
- Generic Name
- Cranioplasty plate, non-alterable FDA UDI
- Model / Reference
- PM623179-A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888233025904 FDA UDI
- 510(k) Number
- K924935 FDA UDI
- FDA Product Code
- KKY FDA UDILZK FDA UDIFWP FDA UDIFZE FDA UDI
- GMDN Term
- Cranioplasty plate, non-alterable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3500 FDA UDI878.3550 FDA UDI878.3680 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cranioplasty plate, non-alterable
Htr-Pmi by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
K924935 also covers:
- HTR-PMI — BIOMET MICROFIXATION, INC
- HTR-PMI — BIOMET MICROFIXATION, INC
- HTR-PMI — BIOMET MICROFIXATION, INC
- HTR-PMI — BIOMET MICROFIXATION, INC
- HTR-PMI — BIOMET MICROFIXATION, INC
- HTR-PMI — BIOMET MICROFIXATION, INC
- HTR-PMI — BIOMET MICROFIXATION, INC
- HTR-PMI — BIOMET MICROFIXATION, INC
- HTR-PMI — BIOMET MICROFIXATION, INC
- HTR-PMI — BIOMET MICROFIXATION, INC
- HTR-PMI — BIOMET MICROFIXATION, INC
- HTR-PMI — BIOMET MICROFIXATION, INC
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 e931d831-654c-4dfb-9fe4-d7fd0553bb7e 35 fields · synced Jun 8, 2026