FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K Number: K933112
·
Decision Feb 17, 1994
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
20
Review Days
237
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Basic Information
- Device Name
- ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
- K Number
- K933112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alphatec Mfg., Inc.
- Date Received
- June 25, 1993
- Decision Date
- February 17, 1994
- 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 Alphatec Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033090 | ICON POLYAXIAL PEDICLE SCREW SYSTEM | Mar 26, 2004 | Substantially Equivalent |
| K023299 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM | Dec 11, 2002 | Substantially Equivalent |
| K020356 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM | Jul 23, 2002 | Substantially Equivalent |
| K993513 | DELTALOC ANTERIOR CERVICAL PLATE SYSTEM | Apr 26, 2000 | Substantially Equivalent |
| K993873 | ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD | Jan 3, 2000 | Substantially Equivalent |
| K992350 | PYLON INTRAMEDULLAARY NAIL SYSTEM | Sep 22, 1999 | Substantially Equivalent |
| K980788 | ALPHATEC WIRE EXTERNAL FIXATION SYSTEM | May 22, 1998 | Substantially Equivalent |
| K964400 | ALPHATEC EXTERNAL FIXATION SYSTEM | Apr 28, 1997 | Substantially Equivalent |
| K951846 | MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS | Feb 14, 1996 | Substantially Equivalent for Some Indications |
| K926417 | ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW | Sep 28, 1994 | Substantially Equivalent |