Identity
- Trade Name
- Biolign Rotoloc FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Roto-Loc Fixed Angled Cervical Screw 4.2 x 12mm FDA UDI
- Model / Reference
- RLFS4212 FDA UDI
- Description
- Roto-Loc Fixed Angled Cervical Screw 4.2 x 12mm FDA UDI
Identifiers
- Catalog Number
- RLFS4212 FDA UDI
- Primary DI / UDI-DI
- 06009708425560 FDA UDI
- 510(k) Number
- K200523 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Millimeter FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
Biolign Rotoloc by Elite Surgical Supplies (pty) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fixation plate, non-bioabsorbable.
- Zavation — ZAVATION · Class II
- Cervalign — Xtant Medical Holdings, Inc. · Class II
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
- TSLP — Synthes · Class II
- AESCULAP — AESCULAP, INC. · Class II
- PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
- ACP — Nuvasive, Inc. · Class II
- uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
Cleared under the same submission
K200523 also covers:
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
- Biolign Rotoloc — ELITE SURGICAL SUPPLIES (PTY) LTD
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
- Elite Surgical Supplies (pty) Ltd
Sources (1)
- FDA UDI 8990b7e7-411e-4e48-866d-eed623422216 36 fields · synced Jun 8, 2026