Identity
- Trade Name
- Dymaxeon FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- In-Situ rod bender FDA UDI
- Model / Reference
- 06.0 FDA UDI
- Description
- In-Situ rod bender FDA UDI
Identifiers
- Catalog Number
- 09.0660 FDA UDI
- Primary DI / UDI-DI
- 00815500025268 FDA UDI
- 510(k) Number
- K121786 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIMNH FDA UDI
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
MR Conditional FDA UDI
Category: Manual orthopaedic bender, reusable
Dymaxeon by Back 2 Basic Direct, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual orthopaedic bender, reusable.
- MESA Small Stature Spinal System — K2M, INC. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Kestrel® — Innovasis, Inc. · Class II
- Surgical Instrument — OSTEONIC CO., Ltd. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Dark Star Deformity — Republic Spine, LLC · Class II
- g Source — GSOURCE, LLC. · Class I
- CLAW CHARLOTTE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
Cleared under the same submission
K121786 also covers:
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
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
- Back 2 Basic Direct, Llc
Sources (1)
- FDA UDI d48f5b98-1e90-4547-9368-c85bc6c36425 36 fields · synced May 30, 2026