Identity
- Trade Name
- ZAVATION DECORTICATOR FDA UDI
- Generic Name
- Orthopaedic fixation plate file/rasp FDA UDI
- Device Name
- TIGER 2 DECORTICATOR FDA UDI
- Model / Reference
- 989-1020-S FDA UDI
- Description
- TIGER 2 DECORTICATOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00197157014476 FDA UDI
- 510(k) Number
- K243908 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic fixation plate file/rasp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation plate file/rasp
Zavation Decorticator by Zavation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate file/rasp.
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- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC · Class I
Cleared under the same submission
K243908 also covers:
- ZAVAATION SCREWDRIVER — ZAVATION
- ZAVATION — ZAVATION
- ZAVATION CADDY — ZAVATION
- ZAVATION CADDY — ZAVATION
- ZAVATION CADDY — ZAVATION
- ZAVATION CADDY — ZAVATION
- ZAVATION CADDY LID — ZAVATION
- ZAVATION COMPRESSOR — ZAVATION
- ZAVATION COUNTER TORQUE WRENCH — ZAVATION
- ZAVATION DILATION TUBE — ZAVATION
- ZAVATION DRIVER — ZAVATION
- ZAVATION DRIVER — ZAVATION
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zavation
Sources (1)
- FDA UDI 453a0f11-cf49-4228-a600-bd72060a4db0 35 fields · synced Jun 1, 2026