FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY
K Number: K872715
·
Decision Dec 7, 1987
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
5
Applicant Total
24
Review Days
150
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Basic Information
- Device Name
- UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY
- K Number
- K872715
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Roseburg SA
- Date Received
- July 10, 1987
- Decision Date
- December 7, 1987
- Product Code
- JDN
- 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 |
|---|---|---|---|
| JDN | Implant, Fixation Device, Spinal | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDN), ordered by most recent decision date.
CANNULATED FEMORAL NAIL
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SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO
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BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM
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NEW C-D SYSTEM FOR SPINAL SURGERY
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TOTAL SPINAL CORRECTION
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Other Clearances by Roseburg SA
| K Number | Device Name | ||
|---|---|---|---|
| K931155 | STAPLE, FIXATION BONE; SCREW FIXATION BONE | Sep 1, 1994 | Substantially Equivalent |
| K890081 | CALIUS-ISABEL CANOVAS SUNGLASSES | Mar 9, 1989 | Substantially Equivalent |
| K885275 | ASSENAT-BLESCHET SUNGLASSES | Jan 24, 1989 | Substantially Equivalent |
| K882392 | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES | Aug 26, 1988 | Substantially Equivalent |
| 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 |