FDA 510(k) K072187, PIONEER LOWTOP SPINAL ROD SYSTEM, by Pioneer Surgical Technology
FDA 510(k) K072187, PIONEER LOWTOP SPINAL ROD SYSTEM, by Pioneer Surgical Technology
FDA 510(k) records for PIONEER LOWTOP SPINAL ROD SYSTEM (K072187), submitted by Pioneer Surgical Technology.
- 510(k) Number: K072187
- Applicant: Pioneer Surgical Technology
- Decision Date: 10/12/2007
- Decision: Substantially Equivalent (SESE)
- Product Code: MNI MNI
- Review Panel: Orthopedic
- Total PDF Pages: 519
- Fully Redacted Pages: 336
- Usable Pages: 183
Sections Included
- Administrative / Introductory Materials: pages 1-362; 79.0% redacted (Heavy Redaction)
- Indications for Use: pages 363-391; 17.2% redacted (Moderate Redaction)
- Performance Testing: pages 392-404; 15.4% redacted (Moderate Redaction)
- Indications for Use: pages 405-408; 0.0% redacted (Unredacted)
- Performance Testing: pages 409; 0.0% redacted (Unredacted)
- Indications for Use: pages 410-513; 39.4% redacted (Heavy Redaction)
- Performance Testing: pages 514-519; 33.3% redacted (Moderate Redaction)
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