FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TS-BONE HIP TOOL
K Number: K063709
·
Decision Jan 4, 2007
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
11
Review Days
21
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Basic Information
- Device Name
- TS-BONE HIP TOOL
- K Number
- K063709
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthopedic Sciences, Inc.
- Date Received
- December 14, 2006
- Decision Date
- January 4, 2007
- 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
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Other Clearances by Orthopedic Sciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133018 | OSI Q SYSTEM ARTHROSCOPES | Feb 26, 2014 | Substantially Equivalent |
| K091398 | ARTHROSCOPE | Aug 26, 2009 | Substantially Equivalent |
| K072175 | TITANIUM HIP TOOL LOCKING PLATE | Aug 21, 2007 | Substantially Equivalent |
| K063033 | MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT | Nov 1, 2006 | Substantially Equivalent |
| K052538 | S-BONE HIP TOOL | Oct 7, 2005 | Substantially Equivalent |
| K051032 | TITANIUM-HIP TOOL | May 23, 2005 | Substantially Equivalent |
| K051181 | CUSTOM-HIP TOOL | May 23, 2005 | Substantially Equivalent |
| K040493 | OUTOLOGOUS SPINAL FIXATION SYSTEM | Sep 3, 2004 | Substantially Equivalent |
| K040850 | TSY SHOULDER PLATE IMPLANT | Jun 24, 2004 | Substantially Equivalent |
| K022139 | HIP TOOL IMPLANT | Sep 23, 2002 | Substantially Equivalent |