Identity
- Trade Name
- 900-021 Dorsal Columella Style 3 Sizer Set FDA UDI
- Generic Name
- Nasal cartilage support implant, non-bioabsorbable FDA UDI
- Device Name
- Nasal Sizer Set FDA UDI
- Model / Reference
- 900-021 FDA UDI
- Description
- Nasal Sizer Set FDA UDI
Identifiers
- Catalog Number
- 900-021 FDA UDI
- Primary DI / UDI-DI
- M7249000211 FDA UDI
- 510(k) Number
- K944166 FDA UDI
- FDA Product Code
- FZE FDA UDI
- GMDN Term
- Nasal cartilage support implant, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Nasal cartilage support implant, non-bioabsorbable
900-021 Dorsal Columella Style 3 Sizer Set by Implantech Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal cartilage support implant, non-bioabsorbable.
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- Nasal Implant — Hanson Medical, Inc. · Class II
- Nasal Implant — Hanson Medical, Inc. · Class II
- MEDPOR — Stryker Leibinger · Class II
- Nasal Implant — Hanson Medical, Inc. · Class II
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC. · Class II
- Nasal Implant — Hanson Medical, Inc. · Class II
Cleared under the same submission
K944166 also covers:
- 900-015 Voloshin Dorsal Columella Sizer Set — Implantech Associates, Inc.
- 900-016 Dorsal Columella Style 1 Sizer Set — Implantech Associates, Inc.
- 900-017 Dorsal Columella Style 5 Sizer Set — Implantech Associates, Inc.
- 900-018 Nasal Dorsum Style 7 Sizer Set — Implantech Associates, Inc.
- 900-019 Nasal Dorsum Style 8 Sizer Set — Implantech Associates, Inc.
- 900-020 Dorsal Columella Syle 2 Sizer Set — Implantech Associates, Inc.
- 900-022 Dorsal Columella Style 4 Sizer Set — Implantech Associates, Inc.
- Dorsal Columella Style 1 — Implantech Associates, Inc.
- Dorsal Columella Style 2 — Implantech Associates, Inc.
- Dorsal Columella Style 3 — Implantech Associates, Inc.
- Dorsal Columella Style 4 — Implantech Associates, Inc.
- Dorsal Columella Style 5 — Implantech Associates, 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
- Implantech Associates, Inc.
Sources (1)
- FDA UDI d692314c-2fab-4c80-86e9-64e289bb5fef 36 fields · synced Jun 9, 2026