Atlas FDA

MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507

FDA 510(k) clearance K052596 · decided 2005-11-15

Clearance details

K-number
K052596
Device name
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507
Applicant
Biopro, Inc.
Decision
Substantially Equivalent
Date received
2005-09-21
Decision date
2005-11-15
Days to decision
55 days
Clearance type
Traditional
Product code
KYI
Device class
2
Regulation number
888.3770
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Port Huron, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (K201072)Ensemble Orthopedics, LLC2020-12-02
Stablyx CMC Arthroplasty Implant System (K180744)Skeletal Dynamics, LLC2018-04-11
STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 (K111068)Skeletal Dynamics, LLC2011-12-30
ASCENSION NUGRIP CMC IMPLANT (K112278)Ascension Orthopedic2011-11-04
EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS (K092548)Extremity Medical, LLC2009-12-15
ARTELON STT SPACER (K061956)Artimplant AB2007-06-07
ARTELON CMC SPACER ARTHRO (K061954)Artimplant AB2007-06-01
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
ASCENSION PYROSPHERE (PCS) (K042690)Ascension Orthopedics, Inc.2004-11-13
ARTELON SPACER CMC-1 (K040070)Artimplant AB2004-09-21

Recalls involving this device

No recalls on record reference this clearance.