Identity
- Trade Name
- LATERA FDA UDI
- Generic Name
- Nasal cartilage support implant, bioabsorbable FDA UDI
- Device Name
- Absorbable Nasal Implant 24mm FDA UDI
- Model / Reference
- LATANI24 FDA UDI
- Description
- Absorbable Nasal Implant 24mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857037006082 FDA UDI
- 510(k) Number
- K161191 FDA UDI
- FDA Product Code
- NHB FDA UDI
- GMDN Term
- Nasal cartilage support implant, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 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
Dimensions & Sizes
- Size
- Length — 24 Millimeter FDA UDI
Category: Nasal cartilage support implant, bioabsorbable
Latera by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal cartilage support implant, bioabsorbable.
- SeptAlign — Spirair · Class II
- SeptAlign — Spirair · Class II
- LATERA — Stryker Corp. · Class II
- LATERA — Stryker Corp. · Class II
- LATERA — Stryker Corp. · Class II
Cleared under the same submission
K161191 also covers:
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
- Stryker Corp.
Sources (1)
- FDA UDI 6061d151-8086-4a2c-9709-d11b5469680c 36 fields · synced Jun 8, 2026