Atlas FDA

ASCENSION PYROSPHERE (PCS)

FDA 510(k) clearance K042690 · decided 2004-11-13

Clearance details

K-number
K042690
Device name
ASCENSION PYROSPHERE (PCS)
Applicant
Ascension Orthopedics, Inc.
Decision
Substantially Equivalent
Date received
2004-09-29
Decision date
2004-11-13
Days to decision
45 days
Clearance type
Traditional
Product code
KYI
Device class
2
Regulation number
888.3770
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Austin, TX, US
Third-party review
No
Expedited review
No

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ARTELON STT SPACER (K061956)Artimplant AB2007-06-07
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ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (K061451)Ascension Orthopedics, Inc.2006-08-11
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 (K061089)Biopro, Inc.2006-06-20
NEXA CARPO METACARPAL IMPLANT (K060386)Nexa Orthopedics, Inc.2006-05-10
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 (K052596)Biopro, Inc.2005-11-15
ARTELON SPACER CMC-1 (K040070)Artimplant AB2004-09-21

Recalls involving this device

No recalls on record reference this clearance.