Identity
- Trade Name
- ProLift Wedge FDA UDI
- Generic Name
- Orthopaedic implantation hammering attachment FDA UDI
- Model / Reference
- 180-104 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190837156077 FDA UDI
- 510(k) Number
- K203361 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic implantation hammering attachment FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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 implantation hammering attachment
ProLift Wedge by Life Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K203361 also covers:
- ProLift Wedge — Life Spine, Inc.
- ProLift Wedge — Life Spine, Inc.
- ProLift Wedge — Life Spine, Inc.
- ProLift Wedge — Life Spine, Inc.
- ProLift Wedge — Life Spine, Inc.
- ProLift Wedge — Life Spine, Inc.
- ProLift Wedge — Life Spine, Inc.
- ProLift Wedge — Life Spine, Inc.
- ProLift Wedge — Life Spine, Inc.
- ProLift Wedge — Life Spine, Inc.
- ProLift Wedge — Life Spine, Inc.
- ProLift Wedge — Life Spine, 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
- Life Spine, Inc.
Sources (1)
- FDA UDI 16ce3c77-ab90-478a-8dfc-b4ded6e3c6ee 33 fields · synced May 30, 2026