International safety notice
Technical Name: Disc replacement interbody spacing device
Brazil / Anvisa · BRA · Nov 29, 2012
Key facts
| Title | Technical Name: Disc replacement interbody spacing device |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | #Product: Shadowteck Lumbar Intervertebral Spacer #Registration No. 80371250007 #Modelos: PSHWPB001 - 7mm; PSHWPB002 - 8mm; PSHWPB003 - 9mm; PSHWPB004 - 10mm; e PSHWPB005 - 11mm #Model PSHWPB001 - Shadowteck Lumbar Intervertebral Spacer - 7mm Lots:PSHW121; #Model PSHWPB002 - Shadowteck Lumbar Intervertebral Spacer - 8mm Lotes:PSHW116; PSHW182;PSHW202 #Model PSHWPB003 - Shadowteck Lumbar Intervertebral Spacer - 9mm Lots:PSHW117;PSHW185;PSHW201 #Model PSHWPB004 - Shadowteck Lumbar Intervertebral Spacer - 10mm Lotes: PSHW118; PSHW187; PSHW200 #Model PSHWPB005 - Shadowteck Lumbar Intervertebral Spacer - 11mm Lotes: PSHW119;PSHW188;PSHW199 |
| Manufacturer | FABRICANTE BIOTECK INDCOMIMP E EXP DE IMPLANTES BIOABSORVÍVEIS LTDA CNPJ 80371250007 ENDEREÇO RUA DRA MARIA AUGUSTA GENEROSO ESTRELA Nº 1060 RUBEM BERTA PORTO ALEGRERS TELEFONE 05132722000 |
| Models | PSHW200, PSHW187, 80371250007, PSHW121, PSHWPB003, PSHW188, PSHW199, PSHW182, PSHW118, PSHW201, PSHWPB002, PSHW181 and 9 more |
| Date | Nov 29, 2012 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1