FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS
K Number: K873005
·
Decision Sep 1, 1987
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
31
Review Days
28
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Basic Information
- Device Name
- TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS
- K Number
- K873005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Techmedica, Inc.
- Date Received
- August 4, 1987
- Decision Date
- September 1, 1987
- 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 Techmedica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933935 | CKS POROUS COATED FEMORAL COMPONENT | Oct 11, 1994 | Substantially Equivalent |
| K932017 | TECHMEDICA CONTINUUM HIP WITH HA COATING | Sep 1, 1994 | Substantially Equivalent |
| K931929 | TECHMEDICA CONTINUUM HIP SYSTEM | Mar 29, 1994 | Substantially Equivalent |
| K926387 | TECHMEDICA STANDARD CEMENTED HIP SYSTEM | Feb 1, 1994 | Substantially Equivalent |
| K925420 | TECHMEDICA STANDARD BIPOLAR SYSTEM | Sep 28, 1993 | Substantially Equivalent |
| K923808 | MULLER STRAIGHT STEM FEMORAL PROSTHESIS | Jul 27, 1993 | Substantially Equivalent |
| K926579 | TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE | Apr 6, 1993 | Substantially Equivalent |
| K911058 | TECHMEDICA CAD/CAM CUSTOM HIP | Feb 23, 1993 | Substantially Equivalent |
| K925181 | TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP | Feb 5, 1993 | Substantially Equivalent |
| K920080 | CONTINUUM KNEE SYSTEM | Sep 1, 1992 | Substantially Equivalent for Some Indications |