Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1308094858
Device Listing 1308094858
Listing Summary
#
Listing key
1308094858
Premarket submission
K941364
Device
ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS
Applicant
Acufex Microsurgical, Inc.
Product code
HRX
Decision date
1994-05-16
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
149131
1219602
1219602
SMITH & NEPHEW INC.
1
N
2026-01-01
ENDOSCOPY 120 FORBES BLVD. SUITE 150 / 130 FORBES BLVD. MANSFIELD MA US 02048
149135
3003604053
3003604053
SMITH & NEPHEW INC.
1
N
2026-01-01
ENDOSCOPY 150 Minuteman Rd ANDOVER MA US 01810
190197
3012358417
3012358417
Lisa Ewing
1
N
2026-01-01
2875 Railroad St Pittsburgh PA US 15222