Identity
- Trade Name
- PARTIAL TILT TOP 3.25MM HEAD OFFSET FDA UDI
- Generic Name
- Ossicular prosthesis, partial FDA UDI
- Device Name
- PARTIAL TILT TOP 3.25MM HEAD OFFSET 1.12MM ID X 6MM L HA/OTOSIL FDA UDI
- Model / Reference
- 252 FDA UDI
- Description
- PARTIAL TILT TOP 3.25MM HEAD OFFSET 1.12MM ID X 6MM L HA/OTOSIL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505000345 FDA UDI
- 510(k) Number
- K972815 FDA UDI
- FDA Product Code
- ETB FDA UDI
- GMDN Term
- Ossicular prosthesis, partial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3450 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
MR Conditional FDA UDI
Category: Ossicular prosthesis, partial
Partial Tilt Top 3.25mm Head Offset by Grace Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ossicular prosthesis, partial.
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH · Class II
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- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- MatriX Stapes Prosthesis Titanium — Heinz Kurz · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Soft CliP Titanium — Heinz Kurz · Class II
Cleared under the same submission
K972815 also covers:
- BOJRAB UNIVERSAL_x000D_ — Grace Medical, Inc.
- BOJRAB UNIVERSAL_x000D_ — Grace Medical, Inc.
- DORNHOFFER FOOTPLATE SHOE — Grace Medical, Inc.
- K-HELIX FOOTPLATE SHOE — Grace Medical, Inc.
- PARTIAL 3MM CENTERED HEAD — Grace Medical, Inc.
- PARTIAL 4MM CENTERED HEAD — Grace Medical, Inc.
- PARTIAL 4MM HEAD NOTCHED — Grace Medical, Inc.
- PARTIAL 4MM HEAD OFFSET — Grace Medical, Inc.
- PARTIAL TILT TOP 3.25MM HEAD NOTCHED — Grace Medical, Inc.
- PARTIAL TILT TOP 3.50MM HEAD NOTCHED — Grace Medical, Inc.
- PARTIAL TILT TOP 3.50MM HEAD OFFSET — Grace Medical, Inc.
- PARTIAL TILT TOP 3MM HEAD CENTERED — Grace Medical, 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
- Grace Medical, Inc.
Sources (1)
- FDA UDI b508deb8-c914-432c-a664-f03bef13626c 35 fields · synced May 30, 2026