FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOMED HAND FUSION SYSTEM
K Number: K111419
·
Decision Oct 7, 2011
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
29
Review Days
140
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OSTEOMED HAND FUSION SYSTEM
- K Number
- K111419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed LP
- Date Received
- May 20, 2011
- Decision Date
- October 7, 2011
- Product Code
- HRS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
FDA 510(k)
FDA Class 2
·Orthopedic
Exalta Proximal Tibia Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
APTUS Clavicle System 2.8
FDA 510(k)
FDA Class 2
·Orthopedic
Pectus Blu System
FDA 510(k)
FDA Class 2
·Orthopedic
Xpert PFP
FDA 510(k)
FDA Class 2
·Orthopedic
Avanti Distal Elbow ORIF System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Osteomed LP
| K Number | Device Name | ||
|---|---|---|---|
| K143338 | Argulated Locking Plates | Apr 1, 2015 | Substantially Equivalent |
| K133691 | EXTRIMILOCK ANKLE PLATING SYSTEM | Feb 24, 2014 | Substantially Equivalent |
| K131445 | OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM | Jun 18, 2013 | Substantially Equivalent |
| K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | Jun 3, 2013 | Substantially Equivalent |
| K123207 | PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM | Nov 29, 2012 | Substantially Equivalent |
| K120015 | OSTEOMED WRIST PLATING SYSTEM | Apr 24, 2012 | Substantially Equivalent |
| K111176 | OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM | Aug 15, 2011 | Substantially Equivalent |
| K102438 | PRIMALOK FACET FIXATION SYSTEM | Sep 30, 2010 | Substantially Equivalent |
| K100354 | PRIMAL OK INTERSPINOUS FUSION SYSTEM | Aug 17, 2010 | Substantially Equivalent |
| K091614 | OSTEOMED FOOT PLATING SYSTEM | Sep 10, 2009 | Substantially Equivalent |