Identity
- Trade Name
- HA LITE ALTO FDA UDI
- Generic Name
- Ossicular prosthesis, total FDA UDI
- Device Name
- HA LITE ALTO TOTAL 15MM LENGTH HA/TITANIUM/SILICONE FDA UDI
- Model / Reference
- 630-M1 FDA UDI
- Description
- HA LITE ALTO TOTAL 15MM LENGTH HA/TITANIUM/SILICONE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505002196 FDA UDI
- 510(k) Number
- K061853 FDA UDI
- FDA Product Code
- ETA FDA UDI
- GMDN Term
- Ossicular prosthesis, total FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3495 FDA UDI
- Commercial Distribution
- Not 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
Ha Lite Alto by Grace Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K061853 also covers:
- ALTO TOTAL — Grace Medical, Inc.
- CENTERED ALTO TOTAL — Grace Medical, Inc.
- DB TITANIUM STRUT — Grace Medical, Inc.
- DORNHOFFER PARTIAL W/WINDOWS 2MM FIXED LEGTH — Grace Medical, Inc.
- FRISBEE PARTIAL — Grace Medical, Inc.
- FRISBEE PARTIAL — Grace Medical, Inc.
- HA ALTO TOTAL — Grace Medical, Inc.
- HA WILDCAT FIXED LENGTH TOTAL — Grace Medical, Inc.
- HABERMAN ALTO PARTIAL RECTANGLE HEAD — Grace Medical, Inc.
- HABERMAN ALTO TOTAL ROUND HEAD — Grace Medical, Inc.
- MIAMI IS COUPLER PARTIAL – LONG — Grace Medical, Inc.
- MIAMI IS COUPLER PARTIAL – SHORT — 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 24d41ce9-c4db-4453-9798-dba256df38bd 36 fields · synced Jun 8, 2026