FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE
K Number: K883784
·
Decision Apr 6, 1989
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
2
Applicant Total
24
Review Days
212
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Basic Information
- Device Name
- TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE
- K Number
- K883784
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Warsaw Orthopedic, Inc.
- Date Received
- September 6, 1988
- Decision Date
- April 6, 1989
- Product Code
- LYQ
- 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 |
|---|---|---|---|
| LYQ | Accessories, Fixation, Spinal Intervertebral Body | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYQ), ordered by most recent decision date.
TRANS-ORAL DEPTH GAUGE
FDA 510(k)
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CASF DRILL GUIDE DG 170
FDA 510(k)
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Other Clearances by Warsaw Orthopedic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892877 | CRADLE, HOSPITAL BED CLOTHING | Jun 15, 1989 | Substantially Equivalent |
| K883783 | TSRH SACRAL SPINAL SCREW | Apr 6, 1989 | Substantially Equivalent for Some Indications |
| K880211 | TSRH H/M HOOK HOLDER | Mar 4, 1988 | Substantially Equivalent |
| K880212 | TSRH H/M HOOK HOLDER W/ROD MOVER | Mar 4, 1988 | Substantially Equivalent |
| K880215 | TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD | Feb 18, 1988 | Substantially Equivalent |
| K880214 | TSRH H/M TORQUE LIMITING WRENCH | Feb 18, 1988 | Substantially Equivalent |
| K870842 | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP | May 27, 1987 | Substantially Equivalent |
| K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | May 27, 1987 | Substantially Equivalent |
| K870830 | WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM | May 4, 1987 | Substantially Equivalent |
| K870846 | SCHULTZ MP COMPONENT PUNCH | Mar 13, 1987 | Substantially Equivalent |