FDA Registration
Active
🇺🇸 United States
ICONN ORTHOPEDICS, LLC
Reg #: 3010887276
·
FEI: 3010887276
·
Expires 2026
Products
7
Proprietary Names
21
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- ICONN ORTHOPEDICS, LLC
- Registration Number
- 3010887276
- FEI Number
- 3010887276
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 400 Union Hill Dr Ste 150
- City
- Birmingham
- State
- AL
- ZIP
- 35209
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181680
Owner / Operator
- Firm Name
- ICONN Orthopedics, LLC
- Operator Number
- 10046864
- Address
- 400 Union Hill Drive, Suite 150
- City
- Birmingham
- State
- AL
- Postal Code
- 35209
- Country
- US
- Correspondent
- Whitt Israel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2018-10-19 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-07-11 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2025-12-15 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2025-12-15 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2020-12-02 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-12-02 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-08-15 |
Proprietary Names
ICONN Answer II Suture Anchor
ICONN Instrument Tray (200001/2)
ICONN Answer 4.75/5.5MM Suture Anchor Awl (247502)
ICONN Square Suture Anchor Drill - Hard Bone, Rigid (225002HR)
ICONN Revolution Knotless Suture Anchor Awl (351004)
ICONN Square Suture Anchor Drill - Rigid (225002R)
ICONN Answer II Awl/Tap (247509)
ICONN Square Suture Anchor Drill (225002)
ICONN Square Suture Anchor Drill - Hard Bone (225002H)
ICONN Square Fish Mouth Drill Guide - Straight (225004SS)
ICONN Square Crown Tip Drill Guide - Straight (225003SH)
ICONN Square Fish Mouth Drill Guide - Curved (225004CS)
ICONN Revolution Knotless Suture Anchor
ICONN Square Suture Anchor Driver - Knotless (225001K)
ICONN Square Suture Anchor Driver - Rigid (225001R)
ICONN Revolution Knotless Suture Anchor Driver (351001)
ICONN Square Suture Anchor Driver (225001)
ICONN Answer II 4.75/5.5MM Suture Anchor Driver (247506)
ICONN Square Blunt Obturator (225006)
ICONN Square Sharp Obturator (225005)
ICONN Campbell Interference Screw
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device