Identity
- Trade Name
- Opteryx® FDA UDI
- Generic Name
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- Ti 6Al 4V (ELI) FDA UDI
- Model / Reference
- CP12 FDA UDI
- Description
- Ti 6Al 4V (ELI) FDA UDI
Identifiers
- Catalog Number
- CP12 FDA UDI
- Primary DI / UDI-DI
- M711CP120 FDA UDI
- 510(k) Number
- K061147 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 — 12 Millimeter FDA UDI
Category: Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
Opteryx® by Innovasis, 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.
- DVR® CROSSLOCKDISTAL VOLAR RADIUS PLATE NARROW RIGHT — Biomet Orthopedics, Inc. · Class II
- PRIMA Proximal Femur Locking Plate System — WISHBONE MEDICAL 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
- OsteoMed — Osteomed Corp. · Class II
- DVR® CROSSLOCKDISTAL VOLAR RADIUS PLATE MEDIUM RIGHT — Biomet Orthopedics, Inc. · Class II
- PRIMA Proximal Femur Locking Plate System — WISHBONE MEDICAL INC. · Class II
- Procedure Kit, Straight Compression Plate, 8 hole with 3.5mm Instruments, Ti — WISHBONE MEDICAL INC. · Class II
Cleared under the same submission
K061147 also covers:
- Opteryx® — Innovasis, Inc.
- Opteryx® — Innovasis, Inc.
- Opteryx® — Innovasis, Inc.
- Opteryx® — Innovasis, Inc.
- Opteryx® — Innovasis, Inc.
- Opteryx® — Innovasis, Inc.
- Opteryx® — Innovasis, Inc.
- Opteryx® — Innovasis, Inc.
- Opteryx® — Innovasis, Inc.
- Opteryx® — Innovasis, Inc.
- Opteryx® — Innovasis, Inc.
- Opteryx® — Innovasis, 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
- Innovasis, Inc.
Sources (1)
- FDA UDI fec608e9-3368-44b3-87d7-5141d2968b8d 37 fields · synced May 30, 2026