PEZO INTERBODY CAGES SYSTEM— 510(k) K103814
Substantially EquivalentUlrich GmbH & Co. KG
FDA 510(k) clearance K103814 for PEZO INTERBODY CAGES SYSTEM, Substantially Equivalent on 2011-03-17. Applicant: Ulrich GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Ulrich GmbH & Co. KG
- Product code
- Code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chesterfield, MO, US
Recent devices under product code MAX
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view all- K252281 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- K251295 — ulrichINJECT CT Motion (XD 8000)
- K241850 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- K233737 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- K210541 — ulrichINJECT CT motion
Adverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.