Identity
- Trade Name
- Total Middle Ear Implant FDA UDI
- Generic Name
- Ossicular prosthesis, total FDA UDI
- Device Name
- Total middle ear implant, fixed size, titanium round-centric head, 5.5x0.3 mm, sterile FDA UDI
- Model / Reference
- 11955 FDA UDI
- Description
- Total middle ear implant, fixed size, titanium round-centric head, 5.5x0.3 mm, sterile FDA UDI
Identifiers
- Catalog Number
- 11955 FDA UDI
- Primary DI / UDI-DI
- 04250381804261 FDA UDI
- 510(k) Number
- K030492 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
- 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
Dimensions & Sizes
- Size
- Length — 5.5 Millimeter FDA UDI
Category: Ossicular prosthesis, total
Total Middle Ear Implant by Spiggle & Theis Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ossicular prosthesis, total.
- TTP-Tuebingen Type AERIAL Total Titanium — Heinz Kurz · Class II
- PRECISE HA LITE TOTAL — Grace Medical, Inc. · Class II
- Sheehy / Polycel® — MEDTRONIC XOMED, INC. · Class II
- TTP-Tuebingen Type AERIAL Total Titanium — Heinz Kurz · Class II
- MNP Total Prosthesis Titanium — Heinz Kurz · Class II
- Duesseldorf Type AERIAL Total Titanium — Heinz Kurz · Class II
- WILDCAT FIXED LENGTH TOTAL, HOLLOW — Grace Medical, Inc. · Class II
- PRECISE OFFSET TOTAL — Grace Medical, Inc. · Class II
Cleared under the same submission
K030492 also covers:
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH
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
- Spiggle & Theis Medizintechnik GmbH
Sources (1)
- FDA UDI 9c9021b7-7859-402e-8214-2e7684568c9b 38 fields · synced Jun 8, 2026