Identity
- Trade Name
- Plateau Ti Curved Instruments FDA UDI
- Generic Name
- Surgical tamp, reusable FDA UDI
- Device Name
- Straight TLIF Tamp, Small FDA UDI
- Model / Reference
- 2019-0066 FDA UDI
- Description
- Straight TLIF Tamp, Small FDA UDI
Identifiers
- Catalog Number
- 2019-0066 FDA UDI
- Primary DI / UDI-DI
- 00190837077440 FDA UDI
- 510(k) Number
- K130630 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Surgical tamp, reusable 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: Surgical tamp, reusable
Plateau Ti Curved Instruments 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
K130630 also covers:
- 10mm x 24mm x 10mm Titanium PLATEAU Interbody, 0° , Straight, Bulleted — Life Spine, Inc.
- 10mm x 24mm x 10mm Titanium PLATEAU Interbody, 7° , Straight, Bulleted — Life Spine, Inc.
- 10mm x 24mm x 12mm Titanium PLATEAU Interbody, 7° , Straight, Bulleted — Life Spine, Inc.
- 10mm x 24mm x 14mm Titanium PLATEAU Interbody, 7° , Straight, Bulleted — Life Spine, Inc.
- 10mm x 24mm x 15mm Titanium PLATEAU Interbody, 7° , Straight, Bulleted — Life Spine, Inc.
- 10mm x 24mm x 16mm Titanium PLATEAU Interbody, 0° , Straight, Bulleted — Life Spine, Inc.
- 10mm x 24mm x 16mm Titanium PLATEAU Interbody, 7° , Straight, Bulleted — Life Spine, Inc.
- 10mm x 24mm x 8mm Titanium PLATEAU Interbody, 0° , Straight, Bulleted — Life Spine, Inc.
- 10mm x 24mm x 9mm Titanium PLATEAU Interbody, 0° , Straight, Bulleted — Life Spine, Inc.
- 10mm x 24mm x 9mm Titanium PLATEAU Interbody, 7° , Straight, Bulleted — Life Spine, Inc.
- 10mm x 28mm x 10mm Titanium PLATEAU Interbody, 0° , Straight, Bulleted — Life Spine, Inc.
- 10mm x 28mm x 11mm Titanium PLATEAU Interbody, 0° , Straight, Bulleted — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Life Spine, Inc.
Sources (1)
- FDA UDI 507466f6-71cc-4934-93af-253e4605e654 35 fields · synced Jun 7, 2026