Identity
- Trade Name
- TRESTLE ANTERIOR CERVICAL PLATING SYSTEM FDA UDI
- Generic Name
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- ANTERIOR CERVICAL PLATE, 2 LEVEL, SIZE 35 FDA UDI
- Model / Reference
- 61002-035 FDA UDI
- Description
- ANTERIOR CERVICAL PLATE, 2 LEVEL, SIZE 35 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844856099210 FDA UDI
- 510(k) Number
- K102820 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Dimensions & Sizes
- Size
- Length — 35 Millimeter FDA UDI
Category: Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
Trestle Anterior Cervical Plating System by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial.
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- Opteryx® — Innovasis, Inc. · Class II
- Opteryx® — Innovasis, Inc. · Class II
- Procedure Kit, Straight Compression Plate, 6 hole with 2.7mm Instruments, Ti — WISHBONE MEDICAL INC. · Class II
- Malleolar Procedure Kit — WISHBONE MEDICAL INC. · Class II
- Opteryx® — Innovasis, Inc. · Class II
Cleared under the same submission
K102820 also covers:
- TRESTLE LUXE — ALPHATEC SPINE, INC.
- TRESTLE LUXE — ALPHATEC SPINE, INC.
- TRESTLE LUXE — ALPHATEC SPINE, INC.
- TRESTLE LUXE — ALPHATEC SPINE, INC.
- TRESTLE LUXE — ALPHATEC SPINE, INC.
- TRESTLE LUXE — ALPHATEC SPINE, INC.
- TRESTLE LUXE — ALPHATEC SPINE, INC.
- TRESTLE LUXE — ALPHATEC SPINE, INC.
- TRESTLE LUXE — ALPHATEC SPINE, INC.
- TRESTLE LUXE — ALPHATEC SPINE, INC.
- TRESTLE LUXE — ALPHATEC SPINE, INC.
- TRESTLE LUXE — ALPHATEC 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
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI b3240c22-3fab-4f3c-b48f-4985f11b5b53 35 fields · synced Jun 8, 2026