FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)
K Number: K961498
·
Decision Feb 6, 1997
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
36
Review Days
294
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Basic Information
- Device Name
- RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)
- K Number
- K961498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica, Inc.
- Date Received
- April 18, 1996
- Decision Date
- February 6, 1997
- 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 Howmedica, Inc.
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|---|---|---|---|
| K984251 | XIA SPINE SYSTEM | Feb 24, 1999 | Substantially Equivalent |
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| K984305 | ZETA MULTIZONE LOCKING NAIL SYSTEM | Feb 1, 1999 | Substantially Equivalent |
| K983885 | BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES | Jan 29, 1999 | Substantially Equivalent |
| K983358 | G/K SFN AND STN LOCKING NAILS | Nov 18, 1998 | Substantially Equivalent |
| K982463 | EXTRACRANIAL RADIOTHERAPY SYSTEM | Sep 30, 1998 | Substantially Equivalent |
| K982248 | HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A | Aug 31, 1998 | Substantially Equivalent |
| K980813 | RELIANCE LONG STEM FEMORAL COMPONENTS | Jun 26, 1998 | Substantially Equivalent |
| K981283 | ROGACHEFSKY DISTAL RADIUS PLATES | Jun 10, 1998 | Substantially Equivalent |
| K980843 | EXETER INTRAMEDULLARY BONE PLUG | Jun 2, 1998 | Substantially Equivalent |