Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BONE GRAFT DELIVERY SYRINGES

K-Number: K941431 · 1994-07-12

ApplicantBio-Interfaces, Inc.
Decision Date1994-07-12
Product CodeEID
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONE GRAFT DELIVERY SYRINGES is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Interfaces, Inc.. It received FDA 510(k) clearance on 1994-07-12 under 510(k) number K941431. The device is classified under product code EID. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE GRAFT DELIVERY SYRINGES?

BONE GRAFT DELIVERY SYRINGES is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Bio-Interfaces, Inc.. The 510(k) number is K941431.

When did BONE GRAFT DELIVERY SYRINGES receive FDA 510(k) clearance?

BONE GRAFT DELIVERY SYRINGES received FDA 510(k) clearance on 1994-07-12, under 510(k) number K941431.

Who is the listed applicant for BONE GRAFT DELIVERY SYRINGES?

The FDA 510(k) record lists Bio-Interfaces, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONE GRAFT DELIVERY SYRINGES?

The FDA product code for BONE GRAFT DELIVERY SYRINGES is EID.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bio-Interfaces, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960164BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140K954763BIO-INTERFACES, INC,. BII-PLASTK950598BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFTK950567BIO-APATITE 6140 HA PARTICLESK950511BLL-FIL 6140 PARTICLESK933688BII-PORE

View all 17 devices →

Related Devices (Code: EID)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K913974ACCESS IMPRESSION BARRELCentrix, Inc.K873153CAULK'S VPS CARTRIDGE SYSTEMDentsply Intl.K871937IMPRESSION SYRINGEDentsply Intl.K863998COLTENE JET-MIXERColtene, Inc.K853282CENTRIX RIBBON TUBESCentrix, Inc.K851386UNITEK DISPOSABLE IMPRESSION SYRINGEUnitek Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑