FDA.reportPublic FDA data

RELIGN CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30127905753012790575RELIGN CORPORATION1N2026-01-011725 De La Cruz Blvd Ste 7 Santa Clara CA US 95050

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00859273007052Dynablator™ - RF probe, disposable(866) 608-0131customer.service@religncorp.com
008592730070833-in-1 SHAVER™ 4.2mm - Multi-functional shaver blade, disposable(866) 608-0131customer.service@religncorp.com
00859273007120Standard Shaver 3.4mm - Standard shaver blade, disposable(866) 608-0131Relign_customerservice@zimmerbiomet.com
008592730071443-in-1 SHAVER™ 5.0mm - Multi-functional shaver blade, disposable(866) 608-0131customer.service@religncorp.com
00859273007175Exoflow™ - Fluid management accessory disposable, outflow only(866) 608-0131customer.service@religncorp.com
00859273007243Curved Standard Shaver 3.4mm - Standard shaver blade, disposable(866) 608-0131Relign_customerservice@zimmerbiomet.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2035531771270163K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)GEI2024-05-08
2035531373305030K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024)GEI2023-11-28
2035531511736902K162770Relign SystemGEI2017-01-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI32024-05-08

PMN#

GUDID#