FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAPLE, FIXATION BONE; SCREW FIXATION BONE
K Number: K931155
·
Decision Sep 1, 1994
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
24
Review Days
541
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Basic Information
- Device Name
- STAPLE, FIXATION BONE; SCREW FIXATION BONE
- K Number
- K931155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Roseburg SA
- Date Received
- March 9, 1993
- Decision Date
- September 1, 1994
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Roseburg SA
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|---|---|---|---|
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| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | Dec 7, 1987 | Substantially Equivalent for Some Indications |
| K874317 | POIRIER KID-ROLLER MANUAL WHEELCHAIR | Nov 17, 1987 | Substantially Equivalent |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Jul 21, 1987 | Substantially Equivalent |
| K871688 | SPECTACLE FRAME - DANIELLE | May 29, 1987 | Substantially Equivalent |
| K871689 | SPECTACLE FRAME - LORRAINE | May 29, 1987 | Substantially Equivalent |
| K870654 | EFER ARTHROSCOPE | May 14, 1987 | Substantially Equivalent |
| K864436 | STAVIP 3000 | Mar 16, 1987 | Substantially Equivalent |