FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTERIOR SPINE SYSTEM
K Number: K934429
·
Decision Oct 20, 1994
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
111
Review Days
402
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Basic Information
- Device Name
- ANTERIOR SPINE SYSTEM
- K Number
- K934429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Buckman Co., Inc.
- Date Received
- September 13, 1993
- Decision Date
- October 20, 1994
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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Other Clearances by Buckman Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961320 | CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM | Jun 25, 1998 | Substantially Equivalent |
| K974641 | FUTURELASE 3000/3002 ERBIUM LASER SYSTEM | Jun 8, 1998 | Substantially Equivalent |
| K964252 | ORTHOCHUCK | May 27, 1997 | Substantially Equivalent |
| K950099 | SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM | Jan 16, 1997 | Substantially Equivalent for Some Indications |
| K960451 | WEBB-MORLEY SPINE SYSTEM | Apr 18, 1996 | Substantially Equivalent for Some Indications |
| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | Jan 25, 1996 | Substantially Equivalent |
| K945756 | IMAGN(TM) 2000 SYSTEM | Dec 19, 1995 | Substantially Equivalent |
| K940003 | VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT | Oct 19, 1995 | Substantially Equivalent |
| K951117 | LIHTAN 532 LASER | Oct 18, 1995 | Substantially Equivalent |
| K942751 | VANGUARD SERIES GAS REGULATORS | Feb 9, 1995 | Substantially Equivalent |